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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Ophthalmic
510(k) Number K211680
Device Name Streamline Surgical System
Applicant
New World Medical, Inc.
10763 Edison Court
Rancho Cucamonga,  CA  91730
Applicant Contact Victor Arellano
Correspondent
New World Medical, Inc.
10763 Edison Court
Rancho Cucamonga,  CA  91730
Correspondent Contact Victor Arellano
Regulation Number880.5725
Classification Product Code
MRH  
Subsequent Product Code
HMX  
Date Received06/01/2021
Decision Date 10/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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