SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
FDA 510(k) clearance K012819 · decided 2001-11-16
Clearance details
- K-number
- K012819
- Device name
- SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
- Applicant
- Semperit Technische Produkte Gesellshaft
- Decision
- Substantially Equivalent
- Date received
- 2001-08-23
- Decision date
- 2001-11-16
- Days to decision
- 85 days
- Clearance type
- Abbreviated
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Apharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.