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FDA 510(k)

A GEL WOUND DRESSING

K-Number: K951862 · 1995-07-12

ApplicantPolymedica Industries, Inc.
Decision Date1995-07-12
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

A GEL WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Polymedica Industries, Inc.. It received FDA 510(k) clearance on 1995-07-12 under 510(k) number K951862. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A GEL WOUND DRESSING?

A GEL WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1995-07-12. The listed applicant is Polymedica Industries, Inc.. The 510(k) number is K951862.

When did A GEL WOUND DRESSING receive FDA 510(k) clearance?

A GEL WOUND DRESSING received FDA 510(k) clearance on 1995-07-12, under 510(k) number K951862.

Who is the listed applicant for A GEL WOUND DRESSING?

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

What is the FDA product code for A GEL WOUND DRESSING?

The FDA product code for A GEL WOUND DRESSING is MGQ.

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Other records listing Polymedica Industries, 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.

K964398SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTEDK971045BASIS FLEXIBLE TIP DIGITAL THERMOMETERK964701MITRAFLEX PIGMENTED WOUND DRESSINGK963623SPYROFLEX PIGMENTED WOUND DRESSINGK962991BASIS BABY-TEMP PACIFIER DIGITAL THEROMETERK955383SPYROCOLLOID WOUND DRESSING

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Related Devices (Code: MGQ)

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.

K171879HylaGuard Moisturizing CreamFounders Science Group, LLCK083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical IncorporatedK041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.K041268SILVERSITE OR CALGITROLAdriK040019SILVERSEALNoble Fiber TechnologiesK040517TENDERWET ACTIVEMedline Industries, Inc.

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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