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510(k) K955455

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

K955455 is an FDA 510(k) premarket notification submitted by Pharmacia Iovision, Inc. for the device "BAERVELT PARS PLANA GLAUCOMA IMPLANT". The FDA issued a decision of Substantially Equivalent on February 18, 1997. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920.

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

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FDA data resources