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510(k) K913628

Device
DISPOSABLE SHOE COVER
Applicant
GEM NONWOVEWS, INC.
510(k) number
K913628
Product code
FXP  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-04
Date received
1991-08-15
Regulation
878.4040
Classification name
Cover, Shoe, Operating-room
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JAMES MCLAUGHLIN
Address
2800-E Bob Wallace Ave. Huntsville AL US 35805 35805

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FXP  #

510(k), Device, Applicant table
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
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

Legacy Summary#

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FDA Review#

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