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FDA 510(k)

SPYROFLEX PIGMENTED WOUND DRESSING

K-Number: K963623 · 1996-10-25

ApplicantPolymedica Industries, Inc.
Decision Date1996-10-25
Product CodeMGP
DecisionSubstantially Equivalent

Device Summary

SPYROFLEX 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 1996-10-25 under 510(k) number K963623. The device is classified under product code MGP. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPYROFLEX PIGMENTED WOUND DRESSING?

SPYROFLEX PIGMENTED WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1996-10-25. The listed applicant is Polymedica Industries, Inc.. The 510(k) number is K963623.

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

SPYROFLEX PIGMENTED WOUND DRESSING received FDA 510(k) clearance on 1996-10-25, under 510(k) number K963623.

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

The FDA product code for SPYROFLEX PIGMENTED WOUND DRESSING 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.

K964398SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTEDK971045BASIS FLEXIBLE TIP DIGITAL THERMOMETERK964701MITRAFLEX PIGMENTED WOUND DRESSINGK962991BASIS BABY-TEMP PACIFIER DIGITAL THEROMETERK955383SPYROCOLLOID WOUND DRESSINGK953885SPYROFLEX SKIN PROTECTOR

View all 16 devices →

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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