SI-PRO
FDA 510(k) clearance K904389 · decided 1990-12-17
Clearance details
- K-number
- K904389
- Device name
- SI-PRO
- Applicant
- David F. Trungale
- Decision
- Substantially Equivalent
- Date received
- 1990-09-26
- Decision date
- 1990-12-17
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- EYF
- Device class
- 1
- Regulation number
- 878.4014
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Brookfield, WI, 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 |
|---|---|---|
| IRRIVAGE (K922785) | Autovage | 1992-10-16 |
| HARDING STERNAL SHIELD (K911407) | Harding Medical Devices | 1991-07-05 |
| ANTI-FOG DISPOSABLE IV INDUCTION COVER (K910104) | Central Plastic, Inc. | 1991-04-12 |
| COMFEEL PROTECTIVE RINGS (K832908) | Coloplast A/S | 1983-12-12 |
Recalls involving this device
No recalls on record reference this clearance.