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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 K062252
Device Name MOLTENO3
Applicant
Iop, Inc.
3184 Airway Ave., Bldg. B
Costa Mesa,  CA  92626
Applicant Contact JASON MALECKA
Correspondent
Iop, Inc.
3184 Airway Ave., Bldg. B
Costa Mesa,  CA  92626
Correspondent Contact JASON MALECKA
Regulation Number886.3920
Classification Product Code
KYF  
Date Received08/03/2006
Decision Date 09/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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