The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Oscillating Saw Blades # So-305,mo-305 And Zo-305.
Device ID | K903650 |
510k Number | K903650 |
Device Name: | OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 |
Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
Contact | Siddharth Desai |
Correspondent | Siddharth Desai MICRO-AIRE SURGICAL INSTRUMENTS, INC. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
Product Code | HWE |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-13 |
Decision Date | 1990-09-14 |