HEMOSTAT, SURGICAL (VARIOUS TYPES)
FDA 510(k) clearance K920883 · decided 1992-03-13
Clearance details
- K-number
- K920883
- Device name
- HEMOSTAT, SURGICAL (VARIOUS TYPES)
- Applicant
- S.T.S Instruments
- Decision
- Substantially Equivalent
- Date received
- 1992-02-26
- Decision date
- 1992-03-13
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- EMD
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Brooklyn, NY, 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 |
|---|---|---|
| HEMOSTAT (K770158) | Deringer-Ney, Inc. | 1977-01-31 |
Recalls involving this device
No recalls on record reference this clearance.