ELLIPSE 12PL, MODEL 9ESL7228
FDA 510(k) clearance K060516 · decided 2006-05-15
Clearance details
- K-number
- K060516
- Device name
- ELLIPSE 12PL, MODEL 9ESL7228
- Applicant
- Danish Dermatologic Development A/S
- Decision
- Substantially Equivalent
- Date received
- 2006-02-27
- Decision date
- 2006-05-15
- Days to decision
- 77 days
- Clearance type
- Abbreviated
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hoersholm, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.