510(k) K851788
- Device
- 29-140 TO 29-196 VARIOUS BONE CHISELS (OSTEOTOMES,
- Applicant
- ARTIBERIA
- 510(k) number
- K851788
- Product code
- FZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-06-20
- Date received
- 1985-04-25
- Regulation
- 878.4800
- Classification name
- Chisel, Surgical, Manual
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GIL M SANCHEZ
- Address
- 4518 Los Ranchitos San Antonio TX US 78233 78233
FDA Registration Numbers#
- 1833920
- 9611503
- 2132732
- 8010298
- 9710524
- 3013247477
- 9610905
- 1030489
- 3039103971
- 3016112537
- 3005739886
- 3013011598
- 2529846
- 9611283
- 3014334038
- 1644408
- 3010287737
- 9680424
- 9616671
- 3012995405
- 3015882686
- 9680735
- 1226544
- 3008711893
- 3009417901
- 3003418325
- 9613369
- 3010123256
- 9611278
- 3031240334
- 3009973336
- 9615857
- 2431166
- 3004371426
- 1643264
- 9614986
- 3010386387
- 3035678069
- 1649518
- 3011365613
- 2134285
- 3010726901
- 3012267976
- 1818910
- 3006395932
- 3000270450
- 3038503932
- 3013784566
- 3010687973
- 3006563559
- 3015895045
- 3008114965
- 2249418
- 1932180
- 2249529
- 3007366790
- 3009703496
- 3007840839
- 3008902714
- 3021666757
- 3036795921
- 3007137643
- 2133928
- 3016825318
- 9680518
- 8010665
- 3014004349
- 3009540749
- 8010257
- 3008285983
- 8010733
- 3020155054
- 1057946
- 3005067367
- 3002834291
- 9611262
- 1646747
- 8043368
- 3017521423
- 3007507973
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K834198 | JAKOBI SURG. INSTRUMENTS #12 40/41 | Imm Enterprises , Ltd. | 1984-01-27 |
Legacy Summary#
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FDA Review#
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