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#
- 9614069
- 3007648354
- 3016894896
- 8040233
- 3030643611
- 3016965929
- 3005587147
- 3005813597
- 9614404
- 9610612
- 1720747
- 3003418325
- 3007064566
- 3012226300
- 3006487092
- 9611283
- 3007773213
- 3008770252
- 1056350
- 2248030
- 3015398570
- 1066741
- 8040263
- 9611062
- 9616250
- 1417592
- 3005440795
- 3015156396
- 9611274
- 3004193466
- 9613079
- 1032347
- 1646747
- 9616246
- 2424531
- 8040278
- 9680515
- 2183301
- 8010732
- 2511556
- 2085199
- 3004552850
- 3045811395
- 8044057
- 9611367
- 3010399422
- 3043625057
- 3005515228
- 8040881
- 3014683120
- 5906
- 3005621335
- 9612278
- 1828464
- 3009718267
- 1032227
- 9680718
- 3013846070
- 3002834291
- 9613926
- 2249529
- 3005061536
- 8010269
- 3014004349
- 8043554
- 3002761766
- 3003244954
- 3011137372
- 3014829979
- 9680026
- 3009756153
- 3008338766
- 9614945
- 3001644167
- 3005528784
- 8043368
- 1836161
- 3003988575
- 3003882387
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases