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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 K925636
Device Name AHMED GLAUCOMA VALVE IMPLANT
Applicant
New World Medical, Inc.
10574 Acacia St., Suite D-1
Rancho Cucamonga,  CA  91730
Applicant Contact MATEEN AHMED
Correspondent
New World Medical, Inc.
10574 Acacia St., Suite D-1
Rancho Cucamonga,  CA  91730
Correspondent Contact MATEEN AHMED
Regulation Number886.3920
Classification Product Code
KYF  
Date Received11/09/1992
Decision Date 11/12/1993
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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