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FDA 510(k)

FRASTEC CONFORMANT DRESSING, VARIOUS SIZES

K-Number: K885325 · 1989-04-17

ApplicantFrastec Wound Care Products, Inc.
Decision Date1989-04-17
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

FRASTEC CONFORMANT DRESSING, VARIOUS SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Frastec Wound Care Products, Inc.. It received FDA 510(k) clearance on 1989-04-17 under 510(k) number K885325. 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 FRASTEC CONFORMANT DRESSING, VARIOUS SIZES?

FRASTEC CONFORMANT DRESSING, VARIOUS SIZES is a medical device that received FDA 510(k) clearance on 1989-04-17. The listed applicant is Frastec Wound Care Products, Inc.. The 510(k) number is K885325.

When did FRASTEC CONFORMANT DRESSING, VARIOUS SIZES receive FDA 510(k) clearance?

FRASTEC CONFORMANT DRESSING, VARIOUS SIZES received FDA 510(k) clearance on 1989-04-17, under 510(k) number K885325.

Who is the listed applicant for FRASTEC CONFORMANT DRESSING, VARIOUS SIZES?

The FDA 510(k) record lists Frastec Wound Care Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRASTEC CONFORMANT DRESSING, VARIOUS SIZES?

The FDA product code for FRASTEC CONFORMANT DRESSING, VARIOUS SIZES is NAD.

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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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