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FDA 510(k)

COPOLYESTER FILM DRESSING

K-Number: K893647 · 1989-10-16

ApplicantTri-State Hospital Supply Corp.
Decision Date1989-10-16
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

COPOLYESTER FILM DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Tri-State Hospital Supply Corp.. It received FDA 510(k) clearance on 1989-10-16 under 510(k) number K893647. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPOLYESTER FILM DRESSING?

COPOLYESTER FILM DRESSING is a medical device that received FDA 510(k) clearance on 1989-10-16. The listed applicant is Tri-State Hospital Supply Corp.. The 510(k) number is K893647.

When did COPOLYESTER FILM DRESSING receive FDA 510(k) clearance?

COPOLYESTER FILM DRESSING received FDA 510(k) clearance on 1989-10-16, under 510(k) number K893647.

Who is the listed applicant for COPOLYESTER FILM DRESSING?

The FDA 510(k) record lists Tri-State Hospital Supply Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPOLYESTER FILM DRESSING?

The FDA product code for COPOLYESTER FILM DRESSING is KGN.

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Other records listing Tri-State Hospital Supply Corp. 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.

K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESK080524CENTURION SORBAVIEW OTCK942353CENTURION UMBILICAL CATHETERK945977CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSINGK931748CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYSK935491CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)

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Related Devices (Code: KGN)

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.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, 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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