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FDA 510(k) Application Details - K140947
Device Classification Name
More FDA Info for this Device
510(K) Number
K140947
Device Name
COMPAT ENTERAL DELIVERY PUMP SETS
Applicant
NESTLE HEALTHCARE NUTRITION, INC.
5353 WAYZATA BOULEVARD, SUITE 505
MINNEAPOLIS, MN 55416 US
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Contact
M.W.(ANDY) ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2014
Decision Date
09/04/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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