Ahmed Glaucoma Valve Model FP8

Implant, Eye Valve

New World Medical, Inc.

The following data is part of a premarket notification filed by New World Medical, Inc. with the FDA for Ahmed Glaucoma Valve Model Fp8.

Pre-market Notification Details

Device IDK171451
510k NumberK171451
Device Name:Ahmed Glaucoma Valve Model FP8
ClassificationImplant, Eye Valve
Applicant New World Medical, Inc. 10763 Edison Court Rancho Cucamonga,  CA  91730
ContactCristina Avalos
CorrespondentCristina Avalos
New World Medical, Inc. 10763 Edison Court Rancho Cucamonga,  CA  91730
Product CodeKYF  
CFR Regulation Number886.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-17
Decision Date2017-08-08
Summary:summary

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