FREE SUN PRO DESIGN 3000 AND 3800
FDA 510(k) clearance K925171 · decided 1992-12-29
Clearance details
- K-number
- K925171
- Device name
- FREE SUN PRO DESIGN 3000 AND 3800
- Applicant
- Free Sun Prod. AB
- Decision
- Substantially Equivalent
- Date received
- 1992-10-14
- Decision date
- 1992-12-29
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- FTC
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Uppsala, Sweden, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.