The following data is part of a premarket notification filed by Microaire with the FDA for Micro-aire Arthros Surg Blades-various Co Prod No..
Device ID | K912206 |
510k Number | K912206 |
Device Name: | MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO. |
Classification | Arthroscope |
Applicant | MICROAIRE 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
Contact | Frans Limonta |
Correspondent | Frans Limonta MICROAIRE 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 | 1991-05-20 |
Decision Date | 1991-08-16 |