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FDA 510(k)

TECNOL GAITERS PRODUCT NUMBER 47725-010

K-Number: K893702 · 1989-06-23

ApplicantTecnol New Jersey Wound Care, Inc.
Decision Date1989-06-23
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TECNOL GAITERS PRODUCT NUMBER 47725-010 is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol New Jersey Wound Care, Inc.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K893702. 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 TECNOL GAITERS PRODUCT NUMBER 47725-010?

TECNOL GAITERS PRODUCT NUMBER 47725-010 is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Tecnol New Jersey Wound Care, Inc.. The 510(k) number is K893702.

When did TECNOL GAITERS PRODUCT NUMBER 47725-010 receive FDA 510(k) clearance?

TECNOL GAITERS PRODUCT NUMBER 47725-010 received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893702.

Who is the listed applicant for TECNOL GAITERS PRODUCT NUMBER 47725-010?

The FDA 510(k) record lists Tecnol New Jersey Wound Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECNOL GAITERS PRODUCT NUMBER 47725-010?

The FDA product code for TECNOL GAITERS PRODUCT NUMBER 47725-010 is FXP.

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Other records listing Tecnol New Jersey Wound Care, Inc. as applicant

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K913043MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKSK911891FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASKK911907FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VISK896193TECNOL LAZER(TM) SURGICAL MASKK894205TECNOL SILK STRIPK891187TECNOL NASO-GASTRIC TUBE HOLDER

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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.K952937NIOMED NON-SKID 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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