510(k) K041019

THE FUGO BLADE FOR GLAUCOMA by Medisurg , Ltd. — Product Code NCR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2004
Date Received
April 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
Device Class
Class II
Regulation Number
886.4100
Review Panel
OP
Submission Type