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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Valve
510(k) Number K902489
Device Name MODIFIED MOLTENO(TM) IMPLANTS
Applicant
Iop, Inc.
22653 Pacific Coast Hwy.
Suite 340
Malibu,  CA  90265
Applicant Contact JASON MALECKA
Correspondent
Iop, Inc.
22653 Pacific Coast Hwy.
Suite 340
Malibu,  CA  90265
Correspondent Contact JASON MALECKA
Regulation Number886.3920
Classification Product Code
KYF  
Date Received05/16/1990
Decision Date 08/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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