The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Drill Modules Models 2116/2117.
| Device ID | K914346 |
| 510k Number | K914346 |
| Device Name: | DRILL MODULES MODELS 2116/2117 |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MICRO SURGICAL INSTRUMENTS CORP. C/O ZIMMER,INC. 24971 AVE.STANFORD WEST Valencia, CA 91355 -1278 |
| Contact | Moe Khosravi |
| Correspondent | Moe Khosravi MICRO SURGICAL INSTRUMENTS CORP. C/O ZIMMER,INC. 24971 AVE.STANFORD WEST Valencia, CA 91355 -1278 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-27 |
| Decision Date | 1991-11-27 |