The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Replacement Surg. Saw Blade.
Device ID | K831714 |
510k Number | K831714 |
Device Name: | MICRO-AIRE REPLACEMENT SURG. SAW BLADE |
Classification | Blade, Saw, General & Plastic Surgery, Surgical |
Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GFA |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-27 |
Decision Date | 1983-07-07 |