SURGISIS STAPLE LINE REINFORCEMENT— 510(k) K022044

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K022044 for SURGISIS STAPLE LINE REINFORCEMENT, Substantially Equivalent on 2002-08-23. Applicant: Cook Biotech, Inc.. Device class: 2.

Clearance details

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