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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 K130690
Device Name Z-800 INFUSION SYSTEM
Applicant
Zyno Medical, LLC
177 Pine St.
Natick,  MA  01760
Applicant Contact MEI ZHANG PHD
Correspondent
Zyno Medical, LLC
177 Pine St.
Natick,  MA  01760
Correspondent Contact MEI ZHANG PHD
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/14/2013
Decision Date 06/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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