The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Replac. Drill Burs For Zimmer.
| Device ID | K821695 |
| 510k Number | K821695 |
| Device Name: | MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER |
| Classification | Burr, Orthopedic |
| Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTT |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-08 |
| Decision Date | 1982-07-20 |