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#
- 3005440795
- 3010442693
- 3045811395
- 3017352116
- 1066741
- 3009255580
- 1056350
- 9681540
- 3015156396
- 3012494290
- 3045742729
- 1000426080
- 3009968482
- 9680026
- 3008797953
- 4488
- 8010665
- 3014937043
- 9681622
- 3012995405
- 3012421607
- 8030607
- 8022787
- 3004193466
- 3002834291
- 8040881
- 3003969055
- 3004417597
- 3003882399
- 3014829979
- 3004992978
- 8043507
- 3011137372
- 1422507
- 3003882387
- 1043214
- 1720747
- 3008808049
- 1646747
- 3015398570
- 3003644849
- 3009171220
- 1055236
- 3012226300
- 9680059
- 2183301
- 9614986
- 3007773213
- 3007675948
- 3030644259
- 1412854
- 3015397788
- 3002769844
- 3048101437
- 2246990
- 3032747418
- 3005621335
- 8040278
- 2436264
- 8041151
- 1054241
- 3007064566
- 3010055973
- 3001146947
- 9614075
- 3013946322
- 3003418325
- 3012104670
- 8010732
- 3011371465
- 9614062
- 8010159
- 9612086
- 2511556
- 3008936260
- 3030643611
- 3001620590
- 9680718
- 9611283
- 3043625057
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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