The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Microtek Mini-max Drill System.
Device ID | K874535 |
510k Number | K874535 |
Device Name: | MICROTEK MINI-MAX DRILL SYSTEM |
Classification | Drill, Bone, Powered |
Applicant | MICROTEK MEDICAL, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
Contact | Keith Mcgee |
Correspondent | Keith Mcgee MICROTEK MEDICAL, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
Product Code | DZI |
CFR Regulation Number | 872.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-03 |
Decision Date | 1987-11-23 |