EXTENDED CHIN IMPLANT STYLE I
FDA 510(k) clearance K902824 · decided 1990-08-01
Clearance details
- K-number
- K902824
- Device name
- EXTENDED CHIN IMPLANT STYLE I
- Applicant
- Implantech Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-28
- Decision date
- 1990-08-01
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- FWP
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or re recall (Z-2211-2013) | Implantech Associates Inc | 2013-09-17 |