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510(k) K012852

EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS by Optonol, Ltd. — Product Code KYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2002
Date Received
August 24, 2001
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

Other clearances by Optonol, Ltd.

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