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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
510(k) Number K153193
Device Name Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
Applicant
Zyno Medical, LLC
177 Pine St.
Natick,  MA  01760
Applicant Contact Mei Zhang
Correspondent
Zyno Medical, LLC
177 Pine St.
Natick,  MA  01760
Correspondent Contact Mei Zhang
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   MEA  
Date Received11/03/2015
Decision Date 08/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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