FDA.report

510(k) K861528

Device
Tecnol Personal Shoe Cover
Applicant
TECHNOL, INC.
510(k) number
K861528
Product code
FXP
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-12
Date received
1986-04-24
Regulation
878.4040
Classification name
Cover, Shoe, Operating-Room
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DAVID ARCHER
Address
7450 Whitehall Fort Worth TX US 76118 76118

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Other 510(k) Records For Product Code FXP

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