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FDA 510(k)

REDI-RELEASE ABSORBENT DRESSING

K-Number: K904604 · 1991-01-07

ApplicantFountain Pharmaceuticals, Inc.
Decision Date1991-01-07
Product CodeKOZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REDI-RELEASE ABSORBENT DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Fountain Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1991-01-07 under 510(k) number K904604. The device is classified under product code KOZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDI-RELEASE ABSORBENT DRESSING?

REDI-RELEASE ABSORBENT DRESSING is a medical device that received FDA 510(k) clearance on 1991-01-07. The listed applicant is Fountain Pharmaceuticals, Inc.. The 510(k) number is K904604.

When did REDI-RELEASE ABSORBENT DRESSING receive FDA 510(k) clearance?

REDI-RELEASE ABSORBENT DRESSING received FDA 510(k) clearance on 1991-01-07, under 510(k) number K904604.

Who is the listed applicant for REDI-RELEASE ABSORBENT DRESSING?

The FDA 510(k) record lists Fountain Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REDI-RELEASE ABSORBENT DRESSING?

The FDA product code for REDI-RELEASE ABSORBENT DRESSING is KOZ.

Related Clinical Trials

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Other records listing Fountain Pharmaceuticals, 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.

K895654SORBEX(TM) SOFT SPONGE

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 SlomoffK896828BIOCLUSIVE(R) ABSORBENT DRESSINGJohnson & Johnson InternationalK903645DERMASORB WOUND CONTACT LAYER DRESSINGConvatec, A Division of E.R. Squibb & SonsK904412ALLEVYN DRESSING CLAIMS CHANGESmith & Nephew United, 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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