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510(k) K030350

EXPRESS MINI GLAUCOMA SHUNT by Optonol, Ltd. — Product Code KYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2003
Date Received
February 3, 2003
Clearance Type
Abbreviated
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.

  • K012852 — EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS (March 26, 2002)

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