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FDA 510(k)

MITRAFLEX CAVITY WOUND DRESSING

K-Number: K935783 · 1994-02-04

ApplicantPolymedica Industries, Inc.
Decision Date1994-02-04
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

MITRAFLEX CAVITY 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 1994-02-04 under 510(k) number K935783. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MITRAFLEX CAVITY WOUND DRESSING?

MITRAFLEX CAVITY WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1994-02-04. The listed applicant is Polymedica Industries, Inc.. The 510(k) number is K935783.

When did MITRAFLEX CAVITY WOUND DRESSING receive FDA 510(k) clearance?

MITRAFLEX CAVITY WOUND DRESSING received FDA 510(k) clearance on 1994-02-04, under 510(k) number K935783.

Who is the listed applicant for MITRAFLEX CAVITY 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 MITRAFLEX CAVITY WOUND DRESSING?

The FDA product code for MITRAFLEX CAVITY WOUND DRESSING is KMF.

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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: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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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