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 |