The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Microaire(r) Facial Bone Plating System.
| Device ID | K914998 |
| 510k Number | K914998 |
| Device Name: | MICROAIRE(R) FACIAL BONE PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Moe Khosravi |
| Correspondent | Moe Khosravi MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-07 |
| Decision Date | 1992-06-02 |