510(k) K902296

TRABECULO-SUPRACHOROIDAL SHUNT by Visionex, Inc. — Product Code KYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1991
Date Received
May 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Valve
Device Class
Class II
Regulation Number
886.3920
Review Panel
OP
Submission Type