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#
- 1057946
- 3017352116
- 9710524
- 1032347
- 3004464325
- 1926681
- 3003694247
- 3011365613
- 1226544
- 3007648354
- 3011024991
- 3023155873
- 3008812560
- 8040233
- 3015895045
- 9611274
- 3003032798
- 1221934
- 3013784566
- 1421101
- 1043534
- 1030489
- 3015516266
- 3010726901
- 3008770252
- 3013422236
- 3006801265
- 3010386387
- 3008992889
- 2249697
- 3027262786
- 3009340886
- 3005739886
- 1058726
- 1836161
- 3013194153
- 1818910
- 3003956316
- 3003435550
- 3005180920
- 9610612
- 3009703496
- 3013055499
- 1417592
- 8010935
- 3006563559
- 3011371465
- 3008902714
- 1424434
- 3015212339
- 9610773
- 8030607
- 3016050940
- 9612074
- 3015882686
- 3021723305
- 3010045785
- 3010123256
- 3012764194
- 3003418325
- 3036795921
- 3010687973
- 1056350
- 9614107
- 9680515
- 3005809810
- 8010733
- 2133687
- 9680735
- 8040278
- 9680026
- 3014334038
- 3004552850
- 9613350
- 2529846
- 3032747418
- 3011302692
- 3004371426
- 1219518
- 3009973336
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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