VersaWrap Tendon Protector— 510(k) K160364
Substantially EquivalentAlafair Biosciences, Inc.
FDA 510(k) clearance K160364 for VersaWrap Tendon Protector, Substantially Equivalent on 2016-06-10. Applicant: Alafair Biosciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Alafair Biosciences, Inc.
- Product code
- Code OWW
- 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
- Austin, TX, US
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