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#
- 3023657851
- 9611112
- 3008583793
- 3003322138
- 3005440795
- 3007507973
- 3004215117
- 2431166
- 9615857
- 1421879
- 1056350
- 3032391
- 8040278
- 8010099
- 3010041511
- 3035678069
- 1923569
- 3010687973
- 9611827
- 9611579
- 3008338766
- 1833053
- 9613926
- 3005083075
- 3007597038
- 3013011598
- 2027754
- 3010399422
- 9681161
- 3010055973
- 1313525
- 3006142527
- 3010699884
- 8043816
- 3012507533
- 3015895045
- 3007289093
- 8010697
- 8010871
- 1032347
- 3024988980
- 3008773560
- 8010704
- 3008285983
- 3015451162
- 1221763
- 1219518
- 3004001706
- 1833986
- 3010667733
- 3010097171
- 1836161
- 8010935
- 3004571672
- 3029082594
- 3007663067
- 9680515
- 1057425
- 9615765
- 1526439
- 9680837
- 1018470
- 8010155
- 2529846
- 8044098
- 3008711893
- 3022505514
- 9611390
- 8043368
- 9616246
- 2434839
- 9611503
- 3033509898
- 3003418325
- 3031564283
- 3008864603
- 1828464
- 3012447612
- 3033536312
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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