STRATASIS SLING KIT— 510(k) K020654

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K020654 for STRATASIS SLING KIT, Substantially Equivalent on 2002-04-09. 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: 2002-02-28
Decision date: 2002-04-09
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.