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FDA 510(k) Application Details - K153193
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K153193
Device Name
Pump, Infusion
Applicant
ZYNO MEDICAL LLC
177 PINE ST
NATICK, MA 01760 US
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Contact
Mei Zhang
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
FRN
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More FDA Info for this Product Code
Date Received
11/03/2015
Decision Date
08/30/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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