The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Sternum Saw Replacement Blades.
Device ID | K850483 |
510k Number | K850483 |
Device Name: | MICRO-AIRE STERNUM SAW REPLACEMENT BLADES |
Classification | Blade, Saw, Surgical, Cardiovascular |
Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
Contact | Gerald Brooks |
Correspondent | Gerald Brooks MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
Product Code | DWH |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-07 |
Decision Date | 1985-03-01 |