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FDA 510(k)

SIS WOUND DRESSING II

K-Number: K993948 · 2000-01-06

ApplicantCook Biotech, Inc.
Decision Date2000-01-06
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

SIS WOUND DRESSING II is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech, Inc.. It received FDA 510(k) clearance on 2000-01-06 under 510(k) number K993948. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIS WOUND DRESSING II?

SIS WOUND DRESSING II is a medical device that received FDA 510(k) clearance on 2000-01-06. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K993948.

When did SIS WOUND DRESSING II receive FDA 510(k) clearance?

SIS WOUND DRESSING II received FDA 510(k) clearance on 2000-01-06, under 510(k) number K993948.

Who is the listed applicant for SIS WOUND DRESSING II?

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

What is the FDA product code for SIS WOUND DRESSING II?

The FDA product code for SIS WOUND DRESSING II is KGN.

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Other records listing Cook Biotech, 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.

K131015BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTK111695HYBRID GRAFTK110402BIODESIGN NIPPLE RECONSTRUCTION CYLINDERK090688COOK UROLOGICAL GRAFTK082682SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUGK082058DYNAMATRIX

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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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