The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Oscillating Saw/ Reciprocating Saw/ Drill-reamer.
Device ID | K870157 |
510k Number | K870157 |
Device Name: | OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER |
Classification | Saw, Pneumatically Powered |
Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
Contact | Siddharth Desai |
Correspondent | Siddharth Desai MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
Product Code | KFK |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-13 |
Decision Date | 1987-02-24 |