510(k) K833602

ROLLER KNIFE-TRANSVERSE -SAGITTAL by Microtek Medical, Inc. — Product Code JYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
October 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Ear
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type