The following data is part of a premarket notification filed by Neo Contemporary Co. with the FDA for Rubin Bone Planer W/replaceable Blade.
| Device ID | K884473 |
| 510k Number | K884473 |
| Device Name: | RUBIN BONE PLANER W/REPLACEABLE BLADE |
| Classification | Rasp, Surgical, General & Plastic Surgery |
| Applicant | NEO CONTEMPORARY CO. 795A SOUTHERN ARTERY Quincy, MA 02169 |
| Contact | Errol B Rubin |
| Correspondent | Errol B Rubin NEO CONTEMPORARY CO. 795A SOUTHERN ARTERY Quincy, MA 02169 |
| Product Code | GAC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-25 |
| Decision Date | 1988-12-09 |