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FDA 510(k)

SORBEX(TM) SOFT SPONGE

K-Number: K895654 · 1990-02-20

ApplicantFountain Pharmaceuticals, Inc.
Decision Date1990-02-20
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

SORBEX(TM) SOFT SPONGE 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 1990-02-20 under 510(k) number K895654. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SORBEX(TM) SOFT SPONGE?

SORBEX(TM) SOFT SPONGE is a medical device that received FDA 510(k) clearance on 1990-02-20. The listed applicant is Fountain Pharmaceuticals, Inc.. The 510(k) number is K895654.

When did SORBEX(TM) SOFT SPONGE receive FDA 510(k) clearance?

SORBEX(TM) SOFT SPONGE received FDA 510(k) clearance on 1990-02-20, under 510(k) number K895654.

Who is the listed applicant for SORBEX(TM) SOFT SPONGE?

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 SORBEX(TM) SOFT SPONGE?

The FDA product code for SORBEX(TM) SOFT SPONGE is NAD.

Related Clinical Trials

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.

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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.

K904604REDI-RELEASE ABSORBENT DRESSING

Related Devices (Code: NAD)

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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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