The following data is part of a premarket notification filed by Microaire with the FDA for Microaire Model 2600.
Device ID | K915670 |
510k Number | K915670 |
Device Name: | MICROAIRE MODEL 2600 |
Classification | Applier, Staple, Surgical, |
Applicant | MICROAIRE 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
Contact | Moe Khosravi |
Correspondent | Moe Khosravi MICROAIRE 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
Product Code | GEF |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-19 |
Decision Date | 1992-03-18 |