The following data is part of a premarket notification filed by Amsco Co. with the FDA for Hall Drill/reamer.
Device ID | K832186 |
510k Number | K832186 |
Device Name: | HALL DRILL/REAMER |
Classification | Motor, Surgical Instrument, Pneumatic Powered |
Applicant | AMSCO CO. 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 | 1983-07-06 |
Decision Date | 1983-08-12 |