The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Twist Lock Drill 1120.
Device ID | K831675 |
510k Number | K831675 |
Device Name: | TWIST LOCK DRILL 1120 |
Classification | Motor, Surgical Instrument, Pneumatic Powered |
Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GET |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-23 |
Decision Date | 1983-06-30 |