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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 K162060
Device Name Ahmed Glaucoma Valve
Applicant
New World Medical, Inc.
10763 Edison Ct.
Rancho Cucamonga,  CA  91730
Applicant Contact SUHAIL ABDULLAH
Correspondent
New World Medical, Inc.
10763 Edison Ct.
Rancho Cucamonga,  CA  91730
Correspondent Contact SUHAIL ABDULLAH
Regulation Number886.3920
Classification Product Code
KYF  
Date Received07/26/2016
Decision Date 10/24/2016
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
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