GENERAL SURGICAL FILES
FDA 510(k) clearance K844145 · decided 1984-11-20
Clearance details
- K-number
- K844145
- Device name
- GENERAL SURGICAL FILES
- Applicant
- Med-Tool, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-23
- Decision date
- 1984-11-20
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GEO
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Louis, MO, 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 |
|---|---|---|
| ORAL SPONGE (K830675) | Unisplint Corp. | 1983-03-24 |
Recalls involving this device
No recalls on record reference this clearance.