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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 K140783
Device Name HALO 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 Received03/31/2014
Decision Date 10/17/2014
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
Recalls CDRH Recalls
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