510(k) K854887
- Device
- MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT
- Applicant
- WALTER LORENZ SURGICAL, INC.
- 510(k) number
- K854887
- Product code
- EMH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-28
- Date received
- 1985-12-06
- 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#
- Contact
- JOEL FADEN
- Address
- Advanced Biosearch Associates 1700 Rockville Pike Suite 320 Rockville MD US 20852 20852
FDA Registration Numbers#
- 3014334038
- 9610809
- 3012421607
- 3005813597
- 9614404
- 3021666757
- 3008902714
- 3003644849
- 3001644167
- 3006142527
- 3007773213
- 3004608878
- 3003882399
- 3012101664
- 8010159
- 8010769
- 9616246
- 9611450
- 9611062
- 2183301
- 3031564283
- 9616250
- 3005440795
- 8044057
- 3004552850
- 3015397788
- 2424531
- 3032747418
- 8043769
- 3014683120
- 3035708926
- 3015393204
- 3005067367
- 3011137372
- 3003431869
- 3016894896
- 8043816
- 8010257
- 1066741
- 2916714
- 3001620590
- 3002834291
- 1055890
- 3003969055
- 3014004349
- 3003759558
- 3013503739
- 3004425647
- 3017352116
- 3005695838
- 9611112
- 1220246
- 3010041511
- 3006487092
- 3003963832
- 3013846070
- 9611390
- 8040233
- 3002769844
- 3002761766
- 1032347
- 3019455
- 3043625057
- 3003882387
- 3015156396
- 3003988575
- 3012226300
- 3003120666
- 9680059
- 8040881
- 3000286616
- 1720747
- 8043368
- 3005621335
- 9611283
- 9614075
- 3003877407
- 3013358456
- 3008338766
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 |
| 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 |
| K771522 | FORCEPS, STYLE #849 | Premier Dental Products Co. | 1977-08-16 |
Legacy Summary#
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FDA Review#
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