The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for Autogenesis(tm) Automator.
| Device ID | K905514 |
| 510k Number | K905514 |
| Device Name: | AUTOGENESIS(TM) AUTOMATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ADVANCED BIOSEARCH ASSN. 3880 BLACKHAWK RD. Danville, CA 94506 -4617 |
| Contact | Rodger J Richeal |
| Correspondent | Rodger J Richeal ADVANCED BIOSEARCH ASSN. 3880 BLACKHAWK RD. Danville, CA 94506 -4617 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-07 |
| Decision Date | 1991-04-02 |