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#
- 1416605
- 3013503739
- 3005528784
- 9616250
- 3003882387
- 9611274
- 2132732
- 3043625057
- 8043368
- 3014004349
- 3006487092
- 9611814
- 1066741
- 1220246
- 3005595283
- 3005440795
- 3008936260
- 9614075
- 9611367
- 2424531
- 3004608878
- 3007648354
- 3001644167
- 8043496
- 3003120666
- 9611112
- 5906
- 3021666757
- 3030644259
- 3002834291
- 3009718267
- 9613083
- 3015393204
- 3009968482
- 8010732
- 3005809810
- 3015398570
- 3012226300
- 2087382
- 9614945
- 8043507
- 2080222
- 9610612
- 9616119
- 3003431869
- 9611062
- 8030607
- 3035708926
- 3031564283
- 2085199
- 3001620590
- 3008808049
- 1032347
- 3003988575
- 3011137372
- 1055890
- 3019455
- 3004552850
- 3003759558
- 3012101664
- 9680026
- 3005067367
- 2248030
- 9614069
- 3015156396
- 3003244954
- 9710524
- 3014937043
- 3005813597
- 3000286616
- 8043988
- 3010399422
- 8043816
- 3003882399
- 3030643611
- 8040263
- 3007773213
- 3014683120
- 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 |
| 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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