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FDA 510(k) Application Details - K970678
Device Classification Name
Accessories, Pump, Infusion
More FDA Info for this Device
510(K) Number
K970678
Device Name
Accessories, Pump, Infusion
Applicant
HARVARD APPARATUS, INC.
22 PLEASANT ST.
S. NATICK, MA 01760 US
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Contact
ERIC J FLACHBART
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
MRZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/24/1997
Decision Date
01/09/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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