SMOOTHSHAPES— 510(k) K053611
Substantially EquivalentBicellulase, Inc.
FDA 510(k) clearance K053611 for SMOOTHSHAPES, Substantially Equivalent on 2006-03-15. Applicant: Bicellulase, Inc.. Device class: 2.
Clearance details
- Applicant
- Bicellulase, Inc.
- Product code
- Code NUV
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newton, MA, US
Recent devices under product code NUV
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