510(k) K834366
- Device
- SURGICAL INSTRUMENTS & ACCESSORIES
- Applicant
- C.B.S. BIOTECHNICS, INC.
- 510(k) number
- K834366
- Product code
- EMH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-02-27
- Date received
- 1983-10-27
- Regulation
- 872.4565
- Classification name
- Forceps, Rongeur, Surgical
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3043625057
- 3003244954
- 3015393204
- 9610612
- 9614945
- 1720747
- 9616246
- 1032227
- 3031564283
- 3017352116
- 8043496
- 9613083
- 3013503739
- 9614069
- 3032747418
- 3009756153
- 1419489
- 3011137372
- 3013273457
- 3008808049
- 3002769844
- 1066741
- 8040278
- 3030643611
- 9616119
- 2424531
- 9611503
- 9611367
- 3009718267
- 3008936260
- 9613348
- 9611390
- 3014829979
- 3048101437
- 3007064566
- 3007773213
- 3003644849
- 3006142527
- 1417592
- 9680718
- 3003963832
- 8040233
- 3012421607
- 3003882387
- 3003969055
- 3030644259
- 9611112
- 3005440795
- 3004049923
- 3015156396
- 3010055973
- 3009968482
- 3016894896
- 9614075
- 3014937043
- 8043554
- 3004425647
- 3003882399
- 8043816
- 3004552850
- 8043368
- 9710524
- 3014615697
- 3043239665
- 3012226300
- 8010769
- 3005515228
- 3002808270
- 3002807120
- 3003877407
- 1421101
- 3005595283
- 3045811395
- 3003759558
- 9680026
- 9614062
- 3005061536
- 5906
- 9614404
- 9612278
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EMH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890255 | BONE RONGEUR, SINGLE-ACTION | Kinetic Medical Products | 1989-01-27 |
| K890256 | BONE RONGEUR, DOUBLE-ACTION | Kinetic Medical Products | 1989-01-27 |
| K854887 | MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT | Walter Lorenz Surgical, Inc. | 1986-02-28 |
| K851710 | 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC | Artiberia | 1985-06-11 |
| K834190 | JAKOBI SURG. INSTRUMENTS #8 15 | Imm Enterprises , Ltd. | 1984-03-06 |
| K821358 | MODIFIED RONGEURS FOR SPINAL & ORTH. S. | Downs Surgical , Ltd. | 1982-05-28 |
| K771522 | FORCEPS, STYLE #849 | Premier Dental Products Co. | 1977-08-16 |
Legacy Summary#
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FDA Review#
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