510(k) K884473
- Device
- RUBIN BONE PLANER W/REPLACEABLE BLADE
- Applicant
- NEO CONTEMPORARY CO.
- 510(k) number
- K884473
- Product code
- GAC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-12-09
- Date received
- 1988-10-25
- Regulation
- 878.4800
- Classification name
- Rasp, Surgical, General & Plastic Surgery
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERROL B RUBIN
- Address
- 795a Southern Artery Quincy MA US 02169 02169
FDA Registration Numbers#
- 3022862651
- 3004571672
- 3007648354
- 9611461
- 3009165919
- 3036756245
- 3003905396
- 8044098
- 3003322138
- 1313525
- 2020601
- 3035678069
- 1720747
- 3003418325
- 9610612
- 8010528
- 3007507973
- 3008285983
- 3008770252
- 9610905
- 1056350
- 2248030
- 3016050940
- 9616250
- 3003597504
- 1417592
- 3008711893
- 3012507533
- 3003694247
- 3005440795
- 1043534
- 3010536692
- 9611274
- 8010935
- 8010433
- 9613079
- 1032347
- 1646747
- 9616246
- 3008773560
- 3012447612
- 8040278
- 1219518
- 9680515
- 1057425
- 9615857
- 1057946
- 3010370500
- 3004552850
- 3004464325
- 3010399422
- 3006563559
- 5906
- 3005621335
- 9612278
- 1828464
- 9680519
- 3008864603
- 3013011598
- 8010155
- 3036795921
- 9680718
- 3005180920
- 9610621
- 3009513193
- 1224360
- 3002834291
- 9613926
- 3005061536
- 3031240334
- 3011137372
- 3033509898
- 9615765
- 3008338766
- 3005528784
- 8043368
- 1836161
- 3001084743
- 8043496
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GAC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K853601 | MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP | Bowen & Company, Inc. | 1985-09-16 |
Legacy Summary#
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FDA Review#
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