PROTHESIS, CHIN, INTERNAL
FDA 510(k) clearance K952709 · decided 1995-08-28
Clearance details
- K-number
- K952709
- Device name
- PROTHESIS, CHIN, INTERNAL
- Applicant
- Spirit Ridge Technologies
- Decision
- Substantially Equivalent
- Date received
- 1995-06-14
- Decision date
- 1995-08-28
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- FZE
- Device class
- 2
- Regulation number
- 878.3680
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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| AART NASAL IMPLANT (K021418) | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 |
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| NASAL DORSAL SERIES (K983755) | Surgical Technology Laboratories, Inc. | 1998-11-20 |
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Recalls involving this device
No recalls on record reference this clearance.