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FDA 510(k)

GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II

K-Number: K901369 · 1990-06-05

ApplicantSterling Drug, Inc.
Decision Date1990-06-05
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Drug, Inc.. It received FDA 510(k) clearance on 1990-06-05 under 510(k) number K901369. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II?

GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II is a medical device that received FDA 510(k) clearance on 1990-06-05. The listed applicant is Sterling Drug, Inc.. The 510(k) number is K901369.

When did GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II receive FDA 510(k) clearance?

GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II received FDA 510(k) clearance on 1990-06-05, under 510(k) number K901369.

Who is the listed applicant for GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II?

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

What is the FDA product code for GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II?

The FDA product code for GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II is KGN.

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Other records listing Sterling Drug, 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.

K896110BIOBRANE(R) IIK875275WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMERK840260PERIOGRAF DURAPATITE 40-60 MESHK820023CONAGRAF TM DURAPATITE CONESK820164EMPTY STERILE CARPUJECTK813257ALVEOGRAF DURAPATITE(18-40 MESH)

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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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