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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 K171451
Device Name Ahmed Glaucoma Valve Model FP8
Applicant
New World Medical, Inc.
10763 Edison Ct.
Rancho Cucamonga,  CA  91730
Applicant Contact Cristina Avalos
Correspondent
New World Medical, Inc.
10763 Edison Ct.
Rancho Cucamonga,  CA  91730
Correspondent Contact Cristina Avalos
Regulation Number886.3920
Classification Product Code
KYF  
Date Received05/17/2017
Decision Date 08/08/2017
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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