The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Implantology Module, Model 2175.
Device ID | K932492 |
510k Number | K932492 |
Device Name: | IMPLANTOLOGY MODULE, MODEL 2175 |
Classification | Plate, Bone |
Applicant | MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
Contact | Shirajul Karim |
Correspondent | Shirajul Karim MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-24 |
Decision Date | 1993-10-05 |