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FDA 510(k)

INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)

K-Number: K901876 · 1990-06-28

ApplicantSmith & Nephew United, Inc.
Decision Date1990-06-28
Product CodeKOZ
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) 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 1990-06-28 under 510(k) number K901876. The device is classified under product code KOZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)?

INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) is a medical device that received FDA 510(k) clearance on 1990-06-28. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K901876.

When did INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) receive FDA 510(k) clearance?

INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) received FDA 510(k) clearance on 1990-06-28, under 510(k) number K901876.

Who is the listed applicant for INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)?

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 CAVITY WOUND DRESSING (LABEL REVISION)?

The FDA product code for INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) is KOZ.

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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: KOZ)

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.

K905206INCARE PINSITE DRESSINGHollister, Inc.K905688CUTINOVA HYDROBeiersdorf, Inc.K905069IODOSORB GELPerstorp AB C/O Robert Joel SlomoffK904604REDI-RELEASE ABSORBENT DRESSINGFountain Pharmaceuticals, Inc.K896828BIOCLUSIVE(R) ABSORBENT DRESSINGJohnson & Johnson InternationalK903645DERMASORB WOUND CONTACT LAYER DRESSINGConvatec, A Division of E.R. Squibb & Sons

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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