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FDA 510(k)

STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS

K-Number: K914702 · 1993-01-29

ApplicantDepuy, Inc.
Decision Date1993-01-29
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1993-01-29 under 510(k) number K914702. The device is classified under product code FXP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS?

STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS is a medical device that received FDA 510(k) clearance on 1993-01-29. The listed applicant is Depuy, Inc.. The 510(k) number is K914702.

When did STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS receive FDA 510(k) clearance?

STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS received FDA 510(k) clearance on 1993-01-29, under 510(k) number K914702.

Who is the listed applicant for STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS?

The FDA 510(k) record lists Depuy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS?

The FDA product code for STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS is FXP.

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Other records listing Depuy, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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Related Devices (Code: FXP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.K971191FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.K970815CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.K961342SHOE COVER, NON-STERILECopioumed Intl., Inc.K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.K952897NIOMED SHOE COVERSAmerasia Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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