510(k) K955455

BAERVELT PARS PLANA GLAUCOMA IMPLANT by Pharmacia Iovision, Inc. — Product Code KYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1997
Date Received
November 29, 1995
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