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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K132841
FOIA Releasable 510(k) K132841
Device Name ZYNO MEDICAL ADMINISTRATION SET
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 Number880.5440
Classification Product Code
FPA  
Date Received09/10/2013
Decision Date 01/23/2014
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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