510(k) K893499

CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS by Cmsi — Product Code EQJ

K893499 is an FDA 510(k) premarket notification submitted by Cmsi for the device "CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS". The FDA issued a decision of Substantially Equivalent on November 16, 1989. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Cmsi has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1989
Date Received
May 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Ear, Nose And Throat
Device Class
Class I
Regulation Number
874.4140
Review Panel
EN
Submission Type