The following data is part of a premarket notification filed by Cmsi with the FDA for Cms Fast Cut, Cms Diamond And Cms Wire Pass.
Device ID | K893499 |
510k Number | K893499 |
Device Name: | CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS |
Classification | Bur, Ear, Nose And Throat |
Applicant | CMSI P.O. BOX 6174 South Bend, IN 46660 |
Product Code | EQJ |
CFR Regulation Number | 874.4140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-04 |
Decision Date | 1989-11-16 |