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#
- 3010097171
- 3003694247
- 3015882686
- 3014334038
- 2529846
- 3005813597
- 1043534
- 3021666757
- 9680424
- 3011530718
- 3011024991
- 1923569
- 3008902714
- 3009703496
- 3003644849
- 3012447612
- 3004608878
- 1057946
- 1825034
- 3042248499
- 3009971621
- 3011302692
- 9616250
- 3005440795
- 3004552850
- 3009590742
- 1926681
- 3017521423
- 2431166
- 2249418
- 3015490794
- 2434839
- 3010687973
- 3011371465
- 3032747418
- 1522875
- 3003807268
- 3013497507
- 3035708926
- 3016069968
- 3006563559
- 3005067367
- 3003431869
- 3011137372
- 3012130008
- 3005641619
- 8010257
- 3038503932
- 2183449
- 2916714
- 1219518
- 3011623994
- 3015177648
- 3002834291
- 3012267976
- 3021723305
- 2249697
- 3014004349
- 1833920
- 9610773
- 8010733
- 9680519
- 3006561161
- 3014662844
- 3008711893
- 3027262786
- 3017352116
- 3005695838
- 3023657851
- 3009962553
- 3012185136
- 3013011598
- 1932180
- 9611112
- 9680518
- 3003435550
- 3010287737
- 3010041511
- 1030489
- 3007751820
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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