The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Micro-aire Sternum Saw 4800.
| Device ID | K894301 |
| 510k Number | K894301 |
| Device Name: | MICRO-AIRE STERNUM SAW 4800 |
| Classification | Saw, Pneumatically Powered |
| Applicant | MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Siddharth Desai |
| Correspondent | Siddharth Desai MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Product Code | KFK |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-23 |
| Decision Date | 1989-08-03 |