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FDA 510(k)

SPYROCOLLOID WOUND DRESSING

K-Number: K955383 · 1995-12-13

ApplicantPolymedica Industries, Inc.
Decision Date1995-12-13
Product CodeMGP
DecisionSubstantially Equivalent for Some Indications

Device Summary

SPYROCOLLOID 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 1995-12-13 under 510(k) number K955383. The device is classified under product code MGP. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SPYROCOLLOID WOUND DRESSING?

SPYROCOLLOID WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1995-12-13. The listed applicant is Polymedica Industries, Inc.. The 510(k) number is K955383.

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

SPYROCOLLOID WOUND DRESSING received FDA 510(k) clearance on 1995-12-13, under 510(k) number K955383.

Who is the listed applicant for SPYROCOLLOID 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 SPYROCOLLOID WOUND DRESSING?

The FDA product code for SPYROCOLLOID 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 DRESSINGK963623SPYROFLEX PIGMENTED WOUND DRESSINGK962991BASIS BABY-TEMP PACIFIER DIGITAL THEROMETERK953885SPYROFLEX 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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