The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Micro Oscillating Saw.
Device ID | K771915 |
510k Number | K771915 |
Device Name: | MICRO OSCILLATING SAW |
Classification | Instrument, Cutting, Orthopedic |
Applicant | AMERICAN STERILIZER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HTZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-12 |
Decision Date | 1977-10-21 |