ORAL SPONGE
FDA 510(k) clearance K830675 · decided 1983-03-24
Clearance details
- K-number
- K830675
- Device name
- ORAL SPONGE
- Applicant
- Unisplint Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-03
- Decision date
- 1983-03-24
- Days to decision
- 21 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
- 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 |
|---|---|---|
| GENERAL SURGICAL FILES (K844145) | Med-Tool, Inc. | 1984-11-20 |
Recalls involving this device
No recalls on record reference this clearance.