510(k) K920883
- Device
- HEMOSTAT, SURGICAL (VARIOUS TYPES)
- Applicant
- S.T.S INSTRUMENTS
- 510(k) number
- K920883
- Product code
- EMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-13
- Date received
- 1992-02-26
- Regulation
- 872.4565
- Classification name
- Hemostat, Surgical
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RIAZ SALEEM
- Address
- 766 E. 9th St. Brooklyn NY US 11230 11230
FDA Registration Numbers#
- 3010055973
- 3012421607
- 2183301
- 3008808049
- 8043507
- 9616250
- 3003882387
- 9681540
- 3043355002
- 3005809810
- 9614986
- 3030643611
- 3011137372
- 3004133929
- 3015997711
- 3004417597
- 3007064566
- 3003431869
- 3038718579
- 3009171220
- 3008338766
- 4488
- 3017352116
- 1066741
- 3008902714
- 3001620590
- 3007518347
- 3001644167
- 3015422158
- 9614062
- 8010732
- 3010288346
- 3000286616
- 1720747
- 8010697
- 3013946322
- 8040881
- 1419489
- 3003969055
- 3030644259
- 3007773213
- 2085199
- 3006380247
- 9681622
- 9611283
- 3004193466
- 2511556
- 3010041511
- 8040278
- 2126670
- 9680026
- 3009340886
- 8041151
- 1836161
- 2411056
- 1055236
- 9611367
- 9613083
- 3003644849
- 3012101664
- 3012104670
- 1646747
- 3002769844
- 3012494290
- 3009496321
- 1000426080
- 3008936260
- 9680059
- 9680718
- 3003418325
- 1412854
- 3004992978
- 3005440795
- 3032747418
- 9680563
- 2320762
- 1056350
- 3017367014
- 3008797953
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EMD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K770158 | HEMOSTAT | Deringer-Ney, Inc. | 1977-01-31 |
Legacy Summary#
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FDA Review#
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