Streamline Surgical System

Pump, Infusion, Ophthalmic

New World Medical, Inc.

The following data is part of a premarket notification filed by New World Medical, Inc. with the FDA for Streamline Surgical System.

Pre-market Notification Details

Device IDK211680
510k NumberK211680
Device Name:Streamline Surgical System
ClassificationPump, Infusion, Ophthalmic
Applicant New World Medical, Inc. 10763 Edison Court Rancho Cucamonga,  CA  91730
ContactVictor Arellano
CorrespondentVictor Arellano
New World Medical, Inc. 10763 Edison Court Rancho Cucamonga,  CA  91730
Product CodeMRH  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-01
Decision Date2021-10-08

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