510(k) K905129

BAERVELDT GLAUCOMA IMPLANT by Wright Medical Corp. — Product Code KYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1991
Date Received
November 14, 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