DAVIS RHYTIDECTOMY
FDA 510(k) clearance K772395 · decided 1978-03-09
Clearance details
- K-number
- K772395
- Device name
- DAVIS RHYTIDECTOMY
- Applicant
- Edward Weck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-27
- Decision date
- 1978-03-09
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- FZI
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MULTIPLE, SURGICAL DRAPE PACK (K911132) | Central Georgia Ancillary Health Systems | 1991-05-06 |
| STERILE DISPOSABLE DRAPE(S) (K910468) | E.M. Adams | 1991-03-21 |
| ELLIPTI-PUNCH (K854159) | Alcon Laboratories | 1985-11-15 |
| KALRN FACE-LIFE SCISSORS (K772394) | Edward Weck, Inc. | 1978-03-09 |
Recalls involving this device
No recalls on record reference this clearance.