SMOOTHKIT+
FDA 510(k) clearance K082004 · decided 2008-09-26
Clearance details
- K-number
- K082004
- Device name
- SMOOTHKIT+
- Applicant
- Osyris
- Decision
- Substantially Equivalent
- Date received
- 2008-07-14
- Decision date
- 2008-09-26
- Days to decision
- 74 days
- Clearance type
- Special
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hellemmes, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.