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FDA 510(k) Application Details - K050107
Device Classification Name
Pump, Infusion
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510(K) Number
K050107
Device Name
Pump, Infusion
Applicant
HARVARD CLINICAL TECHNOLOGY
22 PLEASANT ST.
SOUTH NATICK, MA 01760 US
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Contact
ERIC J FLACHBART
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
01/18/2005
Decision Date
02/11/2005
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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