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FDA 510(k)

SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED

K-Number: K964398 · 1997-10-24

ApplicantPolymedica Industries, Inc.
Decision Date1997-10-24
Product CodeMGP
DecisionSubstantially Equivalent

Device Summary

SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED 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 1997-10-24 under 510(k) number K964398. The device is classified under product code MGP. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED?

SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED is a medical device that received FDA 510(k) clearance on 1997-10-24. The listed applicant is Polymedica Industries, Inc.. The 510(k) number is K964398.

When did SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED receive FDA 510(k) clearance?

SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED received FDA 510(k) clearance on 1997-10-24, under 510(k) number K964398.

Who is the listed applicant for SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED?

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 SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED?

The FDA product code for SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED is MGP.

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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.

K971045BASIS FLEXIBLE TIP DIGITAL THERMOMETERK964701MITRAFLEX PIGMENTED WOUND DRESSINGK963623SPYROFLEX PIGMENTED WOUND DRESSINGK962991BASIS BABY-TEMP PACIFIER DIGITAL THEROMETERK955383SPYROCOLLOID WOUND DRESSINGK953885SPYROFLEX SKIN PROTECTOR

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Related Devices (Code: MGP)

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.

K012995COLLATEK SHEETBiocore Medical Technologies, Inc.K012997COLLATEK FOAMBiocore Medical Technologies, Inc.K001508LASERSKIN DRESSINGFidia Advanced Biopolymers SrlK990079FASTSEAL CHEST WOUND DRESSINGGreenfield Medical Technologies, Inc.K991214SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSDermaphylyx, 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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