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#
- 3006128100
- 3009962553
- 3005813597
- 9614986
- 3006563559
- 2183449
- 9610612
- 3008650117
- 1219518
- 3014334038
- 9611579
- 3013194153
- 3008711893
- 3015490794
- 3021519357
- 9616250
- 9611262
- 2431166
- 9614107
- 3005809810
- 3009590742
- 8010177
- 3010287737
- 3036795921
- 3033509898
- 9680518
- 8044098
- 9680424
- 3015177648
- 3039103971
- 3014004349
- 3005067367
- 8010935
- 3009971621
- 3018094310
- 3006561161
- 1421101
- 3015895045
- 9680059
- 1833824
- 3012445569
- 3009540749
- 9617426
- 2249697
- 3004371426
- 3008388427
- 3005695838
- 3004608878
- 3003597504
- 1644408
- 3006395932
- 3007751820
- 1424434
- 9611278
- 8010733
- 3010097171
- 3009703496
- 3011365613
- 1032347
- 9616671
- 8043792
- 1526439
- 9710524
- 1818910
- 3011371465
- 3016069968
- 3006460162
- 1923569
- 3011530718
- 8040179
- 3042248499
- 3013497507
- 3008812560
- 1058726
- 3002675176
- 3016112537
- 9611274
- 9611112
- 3010726901
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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