510(k) K050933

FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 by Medisurg , Ltd. — Product Code NCR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2005
Date Received
April 14, 2005
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