510(k) K771522
- Device
- FORCEPS, STYLE #849
- Applicant
- Premier Dental Products Co.
- 510(k) number
- K771522
- Product code
- EMH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-16
- Date received
- 1977-08-08
- Regulation
- 872.4565
- Classification name
- Forceps, Rongeur, Surgical
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010055973
- 3012421607
- 2183301
- 2248030
- 3008808049
- 8043507
- 1032347
- 9616250
- 1828464
- 8044057
- 3003882387
- 3013358456
- 3005809810
- 8010769
- 3005515228
- 8010257
- 3030643611
- 3027615
- 9613079
- 3011137372
- 9611390
- 8043769
- 1220246
- 3007064566
- 8010269
- 9610809
- 3015393204
- 3003431869
- 9611112
- 3009171220
- 3002807115
- 3008338766
- 3002808270
- 3017352116
- 1066741
- 3008902714
- 3031564283
- 3001620590
- 3001644167
- 3004049923
- 1055890
- 9614062
- 3003120666
- 8010732
- 9611062
- 9611814
- 1417592
- 3000286616
- 3004425647
- 9611450
- 1720747
- 3014004349
- 8040881
- 1419489
- 3003969055
- 3030644259
- 3007773213
- 2085199
- 9611274
- 9611283
- 3014683120
- 3014615697
- 9613348
- 3004193466
- 8043368
- 9614945
- 3013503739
- 3004215117
- 3010041511
- 8040278
- 2511556
- 3003988575
- 9710524
- 9680026
- 3009340886
- 3009718267
- 9614069
- 1836161
- 8043554
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 |
| K834366 | SURGICAL INSTRUMENTS & ACCESSORIES | C.B.S. Biotechnics, Inc. | 1984-02-27 |
| K821358 | MODIFIED RONGEURS FOR SPINAL & ORTH. S. | Downs Surgical , Ltd. | 1982-05-28 |