510(k) K890256
- Device
- BONE RONGEUR, DOUBLE-ACTION
- Applicant
- KINETIC MEDICAL PRODUCTS
- 510(k) number
- K890256
- Product code
- EMH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-27
- Date received
- 1989-01-18
- 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
- JAMES I LAUGHNER
- Address
- 4934 Peach St. Erie PA US 16509 16509
FDA Registration Numbers#
- 9611062
- 9614062
- 8043769
- 3008338766
- 9614069
- 3015393204
- 1421101
- 9616250
- 3016894896
- 2080222
- 5906
- 1032227
- 1836161
- 3006487092
- 9611503
- 3007648354
- 3019455
- 3045811395
- 3003963832
- 3013846070
- 8010269
- 3048101437
- 3004193466
- 3005621335
- 3003759558
- 2087382
- 9680718
- 1056350
- 3008902714
- 3004425647
- 2424531
- 8010168
- 8040278
- 8040263
- 3043625057
- 3001644167
- 3005061536
- 1066741
- 3005440795
- 3027615
- 3005067367
- 1419489
- 3003882399
- 8043496
- 3002807115
- 3003877407
- 9613926
- 3005587147
- 8040881
- 3007773213
- 3006142527
- 2511556
- 3009968482
- 9611283
- 1421879
- 9614404
- 9611112
- 3000286616
- 9613348
- 3031564283
- 3005809810
- 3021666757
- 3012226300
- 3010055973
- 3002769844
- 3030644259
- 3003969055
- 9610612
- 8010257
- 9611367
- 8010159
- 3035708926
- 3003988575
- 9612086
- 3010041511
- 8030607
- 9612278
- 8043554
- 9616119
- 1412854
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 |
| 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 |
| K771522 | FORCEPS, STYLE #849 | Premier Dental Products Co. | 1977-08-16 |
Legacy Summary#
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FDA Review#
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