MODEL UCA / SPEC SYSTEM UCA
FDA 510(k) clearance K875305 · decided 1988-01-27
Clearance details
- K-number
- K875305
- Device name
- MODEL UCA / SPEC SYSTEM UCA
- Applicant
- Spec Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-29
- Decision date
- 1988-01-27
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- FZH
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kernersville, NC, 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 |
|---|---|---|
| CARDIO-PAK LAPAROTOMY PACK (K923233) | Cardio-Med-Associates, Inc. | 1993-03-20 |
| ULTRAFLOW (K871901) | Custom Industries, Inc. | 1987-06-01 |
| OPERATING ROOM VENTILATOR (K770084) | Dupaco, Inc. | 1977-02-23 |
Recalls involving this device
No recalls on record reference this clearance.