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#
- 3008711893
- 1221934
- 3019878714
- 3016825318
- 3021519357
- 9611579
- 1032347
- 3010197239
- 9616250
- 3016069968
- 1818910
- 3013247477
- 3003694247
- 8044098
- 3015399803
- 3021723305
- 3005809810
- 3006128100
- 9614986
- 8010257
- 3005641619
- 3007024186
- 2183449
- 3009973336
- 9613079
- 3011137372
- 3033536312
- 3004371426
- 9616671
- 3009703496
- 2027467
- 3002675176
- 3016112537
- 3033509898
- 1822565
- 3003120897
- 3003431869
- 3007751820
- 3011024991
- 9611112
- 1825034
- 3020155054
- 3008114965
- 3008338766
- 3017352116
- 3008285983
- 3008902714
- 1834379
- 2249418
- 8010935
- 3015895045
- 1833920
- 3027262786
- 3010726901
- 9610773
- 3009513193
- 1058726
- 3003435550
- 3023657851
- 1417592
- 3008992889
- 3012447612
- 3015516266
- 3009499159
- 3000286616
- 3035678069
- 1720747
- 1649518
- 3010235355
- 3013194153
- 1522875
- 3014004349
- 3006460162
- 9680519
- 3038503932
- 3013011598
- 9611274
- 3010667733
- 3011623994
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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