The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Arthroscopic Surgery Blades Dy-3440, 3443, 3444.
| Device ID | K901735 |
| 510k Number | K901735 |
| Device Name: | ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 |
| Classification | Arthroscope |
| Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Frans Limonta |
| Correspondent | Frans Limonta MICRO-AIRE SURGICAL INSTRUMENTS, INC. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-17 |
| Decision Date | 1990-06-20 |