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#
- 8010155
- 1221934
- 1417592
- 9615857
- 3013247477
- 3006460162
- 3009590742
- 8010547
- 2431166
- 3010097171
- 3020155054
- 3013784566
- 3010611926
- 3010041511
- 9611274
- 9680515
- 3012447612
- 3010386387
- 9613079
- 3015516266
- 3010123256
- 3032747418
- 1030489
- 3011371465
- 3008285983
- 1833920
- 3007840839
- 3012995405
- 3007024186
- 3008110533
- 9680735
- 1836161
- 1056350
- 3006128100
- 3010235355
- 1526439
- 1058726
- 9616250
- 3016069968
- 3033536312
- 9710524
- 3009499159
- 9610773
- 2133928
- 3012185136
- 1825034
- 3010071016
- 9612075
- 1424434
- 3010197239
- 8010665
- 1313525
- 3035678069
- 3007751820
- 2434839
- 8030607
- 3010287737
- 3000270450
- 3008902714
- 3039103971
- 9610612
- 1646747
- 3008388427
- 3005528784
- 9614986
- 1643264
- 1043534
- 9611278
- 3003956316
- 9680519
- 3009962553
- 3009540749
- 9680424
- 3016825318
- 8040278
- 3023155873
- 3009417901
- 3011137372
- 1649518
- 3015179588
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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