MULTIPLE, SURGICAL DRAPE PACK
FDA 510(k) clearance K911132 · decided 1991-05-06
Clearance details
- K-number
- K911132
- Device name
- MULTIPLE, SURGICAL DRAPE PACK
- Applicant
- Central Georgia Ancillary Health Systems
- Decision
- Substantially Equivalent
- Date received
- 1991-03-14
- Decision date
- 1991-05-06
- Days to decision
- 53 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
- Macon, GA, 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 |
|---|---|---|
| STERILE DISPOSABLE DRAPE(S) (K910468) | E.M. Adams | 1991-03-21 |
| ELLIPTI-PUNCH (K854159) | Alcon Laboratories | 1985-11-15 |
| DAVIS RHYTIDECTOMY (K772395) | Edward Weck, Inc. | 1978-03-09 |
| KALRN FACE-LIFE SCISSORS (K772394) | Edward Weck, Inc. | 1978-03-09 |
Recalls involving this device
No recalls on record reference this clearance.