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#
- 3010667733
- 3007597038
- 3005528784
- 9616250
- 9610905
- 3025603301
- 9611274
- 3036795921
- 1043534
- 3011371465
- 8043368
- 3008114965
- 3003905396
- 3005440795
- 3001084743
- 3033536312
- 3008936260
- 3007289093
- 3004608878
- 3007648354
- 3012995405
- 8043496
- 9611262
- 5906
- 9611112
- 9680519
- 2529846
- 3012234585
- 3002834291
- 1923569
- 3005809810
- 1833053
- 9610612
- 1057425
- 8010099
- 9616119
- 3003431869
- 3003694247
- 8030607
- 3024988980
- 3031564283
- 1224360
- 3004638532
- 1032347
- 3011137372
- 1055890
- 3003407244
- 3004552850
- 3004571672
- 8010665
- 1932180
- 9681161
- 3005067367
- 8010155
- 2248030
- 3009590742
- 3005180920
- 3022505514
- 3000286616
- 9680837
- 3010399422
- 3031240334
- 2431166
- 8043816
- 9611827
- 3034688516
- 3010536692
- 3024706750
- 9611278
- 3012656745
- 3004001706
- 3029082594
- 2133928
- 1219518
- 3008338766
- 3036756245
- 3010041511
- 1018470
- 3009165919
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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