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FDA 510(k) Application Details - K141273
Device Classification Name
Accessories, Pump, Infusion
More FDA Info for this Device
510(K) Number
K141273
Device Name
Accessories, Pump, Infusion
Applicant
WELLDOC, INC
1501 SAINT PAUL STREET
SUITE 118
BALTIMORE, MD 21202 US
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Contact
DIVYA KALLAMADI
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
05/16/2014
Decision Date
07/08/2014
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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