Product code FXP

Product
Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical De
Definition
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Description
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Regulation number
Radiation type
Radiation Emitting Electronic Product Codes // Qui
Applicable standards
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -

Current FDA Classification

Device name
Cover, Shoe, Operating-Room
Medical specialty
General, Plastic Surgery
Device class
1
Regulation number
878.4040
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related Records

Related 510(k) Records

510(k)DeviceApplicantDecision date
K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.1998-01-13
K971191FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.1997-07-10
K970815CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.1997-03-27
K961342SHOE COVER, NON-STERILECopioumed Intl., Inc.1996-12-30
K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.1996-11-19
K952937NIOMED NON-SKID SHOE COVERSAmerasia Corp.1995-10-23
K952897NIOMED SHOE COVERSAmerasia Corp.1995-10-23
K943034OREX SHOE COVERSThantex Specialties, Inc.1995-01-02
K932738KAPPLER PRO/VENT BOOTKappler, Inc.1994-03-29
K925815REUSABLE LIQUIDPROOF BOOTIEAmsco Sterile Recoveries, Inc.1993-07-09
K914702STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTSDepuy, Inc.1993-01-29
K913628DISPOSABLE SHOE COVERGem Nonwovews, Inc.1991-10-04
K894383DISPOSABLE SHOE COVERAmerican Threshold Industries, Inc.1989-09-12
K893702TECNOL GAITERS PRODUCT NUMBER 47725-010Tecnol New Jersey Wound Care, Inc.1989-06-23
K883657SKID RESISTANT, LONG LASTING SHOE COVERSJames River Corp.1988-09-15
K882280COVER, SHOE OPERATING ROOMA Plus International, Inc.1988-06-23
K882128TECNOL TIGER PAWS PRODUCT NUMBER 47705-010Tecnol New Jersey Wound Care, Inc.1988-06-15
K880093CARETEX SKID RESISTANT SHOE COVERSJames River Corp.1988-01-29
K874064SHOE COVERSInterpro Intl., Inc.1987-11-04
K872797NON-SKID SHOE COVERSAbco Dealers, Inc.1987-08-04
K865023COVER, SHOE OPERATING ROOMUlti-Med Intl., Inc.1987-01-12
K864550CARETEX SHOE COVERSJames River Corp.1986-12-24
K864026NONCONDUCTIVE SHOE COVERKimberly-Clark Corp.1986-10-30
K862726DISPOSABLE SHOE COVERS AND NURSES CAPSAbco Dealers, Inc.1986-08-01
K861528TECNOL PERSONAL SHOE COVERTechnol, Inc.1986-05-12
K851554OVERSHOES (SURCHAUSSURESRoseburg SA1985-04-30
K844705SHOE COVERSMedicon, Inc.1985-01-10
K843475PHARMA-PLAST SINGLE USE OVERSHOESZimmar Consulting , Ltd.1984-10-31
K830821MICRO-MITTCooperVision, Inc.1983-04-27
K801617CONDUCTIVE SHOE COVERSProcter & Gamble Mfg. Co.1980-08-04

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