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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 K120685
Device Name ZYNO MEDICAL ADMINISTRATION SET
Applicant
Zyno Medical, LLC
10 Tech Circle
Natick,  MA  01760
Applicant Contact CHAOYOUNG LEE
Correspondent
Zyno Medical, LLC
10 Tech Circle
Natick,  MA  01760
Correspondent Contact CHAOYOUNG LEE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/06/2012
Decision Date 09/07/2012
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
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