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FDA 510(k)

INTRASITE HYDROCOLLOID WOUND DRESSING

K-Number: K911660 · 1991-06-17

ApplicantSmith & Nephew United, Inc.
Decision Date1991-06-17
Product CodeMGP
DecisionSubstantially Equivalent

Device Summary

INTRASITE HYDROCOLLOID WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew United, Inc.. It received FDA 510(k) clearance on 1991-06-17 under 510(k) number K911660. The device is classified under product code MGP. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRASITE HYDROCOLLOID WOUND DRESSING?

INTRASITE HYDROCOLLOID WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1991-06-17. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K911660.

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

INTRASITE HYDROCOLLOID WOUND DRESSING received FDA 510(k) clearance on 1991-06-17, under 510(k) number K911660.

Who is the listed applicant for INTRASITE HYDROCOLLOID WOUND DRESSING?

The FDA 510(k) record lists Smith & Nephew United, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRASITE HYDROCOLLOID WOUND DRESSING?

The FDA product code for INTRASITE HYDROCOLLOID WOUND DRESSING is MGP.

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Other records listing Smith & Nephew United, 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.

K963096ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSINGK961775PROFORE FOUR-LAYER BANDAGE SYSTEM KITK945330ALLEVYN ADHESIVEK943619CAVI-CARE CONFORMING FOAM DRESSINGK942748INTRASITEK935705ALLEVYN ISLAND WOUND DRESSING

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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.

K012997COLLATEK FOAMBiocore Medical Technologies, Inc.K012995COLLATEK SHEETBiocore 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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