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FDA 510(k)

FLUID BARRIER BOOT KNEE & ANKLE-HIGH

K-Number: K955835 · 1996-11-19

ApplicantInstrument Makar, Inc.
Decision Date1996-11-19
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLUID BARRIER BOOT KNEE & ANKLE-HIGH is the device name listed in this FDA 510(k) record. The listed applicant is Instrument Makar, Inc.. It received FDA 510(k) clearance on 1996-11-19 under 510(k) number K955835. 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 FLUID BARRIER BOOT KNEE & ANKLE-HIGH?

FLUID BARRIER BOOT KNEE & ANKLE-HIGH is a medical device that received FDA 510(k) clearance on 1996-11-19. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K955835.

When did FLUID BARRIER BOOT KNEE & ANKLE-HIGH receive FDA 510(k) clearance?

FLUID BARRIER BOOT KNEE & ANKLE-HIGH received FDA 510(k) clearance on 1996-11-19, under 510(k) number K955835.

Who is the listed applicant for FLUID BARRIER BOOT KNEE & ANKLE-HIGH?

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

What is the FDA product code for FLUID BARRIER BOOT KNEE & ANKLE-HIGH?

The FDA product code for FLUID BARRIER BOOT KNEE & ANKLE-HIGH is FXP.

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Other records listing Instrument Makar, 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.

K002600LITWIN CRUICATE ANCHORK980999ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTK963396BIOSPHERE SUTURE ANCHORK964364DISPOSABLE APRONK960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHORK943249BIOABSORBABLE INTERFERENCE SCREW

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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.K952937NIOMED NON-SKID SHOE COVERSAmerasia Corp.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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