COOK UROLOGICAL GRAFT— 510(k) K090688

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K090688 for COOK UROLOGICAL GRAFT, Substantially Equivalent on 2009-07-10. Applicant: Cook Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Cook Biotech, Inc.
Product code: Code PAG
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2009-03-16
Decision date: 2009-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.