The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro Oscillating Saw.
Device ID | K811834 |
510k Number | K811834 |
Device Name: | MICRO OSCILLATING SAW |
Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HSZ |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-30 |
Decision Date | 1981-07-20 |