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#
- 3003882399
- 3015156396
- 3030644259
- 3038718579
- 3005440795
- 8043507
- 2080222
- 1056350
- 2511556
- 8040278
- 3012101664
- 3010041511
- 3015422158
- 3009049852
- 3003963832
- 3006487092
- 3008797953
- 3008338766
- 9681540
- 9611283
- 3015397788
- 3004193466
- 9613926
- 8040881
- 9680718
- 3010055973
- 2320762
- 3007518347
- 8010159
- 1054241
- 3001146947
- 3009340886
- 3009255580
- 3008808049
- 8010697
- 3001620590
- 3006380247
- 3002769844
- 3013946322
- 3014937043
- 8041151
- 3004133929
- 1000426080
- 1836161
- 9614075
- 3035708926
- 9680515
- 1419489
- 3003644849
- 3010288346
- 1043214
- 3012421607
- 1422507
- 9680563
- 3012104670
- 3012226300
- 9614062
- 3003418325
- 9611367
- 2126670
- 2085199
- 9616250
- 1055236
- 3004992978
- 2436264
- 3007675948
- 3011137372
- 1646747
- 3014829979
- 2183301
- 1066741
- 3002834291
- 3009968482
- 9612086
- 9681622
- 3003431869
- 9613083
- 3017352116
- 3007773213
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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