510(k) K080067

ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER by Iscience Interventional — Product Code MPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2008
Date Received
January 10, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type