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FDA 510(k) Application Details - K130690
Device Classification Name
Pump, Infusion
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510(K) Number
K130690
Device Name
Pump, Infusion
Applicant
ZYNO MEDICAL LLC
177 PINE ST
NATICK, MA 01760 US
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Contact
MEI ZHANG PHD
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
FRN
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More FDA Info for this Product Code
Date Received
03/14/2013
Decision Date
06/12/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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