SURGISIS STAPLE LINE REINFORCEMENT— 510(k) K022044
Substantially EquivalentCook 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
Recent devices under product code OXE
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