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FDA 510(k)

MITRAFLEX PIGMENTED WOUND DRESSING

K-Number: K964701 · 1997-02-07

ApplicantPolymedica Industries, Inc.
Decision Date1997-02-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MITRAFLEX PIGMENTED 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 1997-02-07 under 510(k) number K964701. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITRAFLEX PIGMENTED WOUND DRESSING?

MITRAFLEX PIGMENTED WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1997-02-07. The listed applicant is Polymedica Industries, Inc.. The 510(k) number is K964701.

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

MITRAFLEX PIGMENTED WOUND DRESSING received FDA 510(k) clearance on 1997-02-07, under 510(k) number K964701.

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

The FDA product code for MITRAFLEX PIGMENTED WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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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 THERMOMETERK963623SPYROFLEX PIGMENTED WOUND DRESSINGK962991BASIS BABY-TEMP PACIFIER DIGITAL THEROMETERK955383SPYROCOLLOID WOUND DRESSINGK953885SPYROFLEX SKIN PROTECTOR

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Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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