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FDA 510(k) Application Details - K142319
Device Classification Name
More FDA Info for this Device
510(K) Number
K142319
Device Name
SCIg60 Infuser, Infuset
Applicant
EMED TECHNOLOGIES CORPORATION
1264 Hawks Flight Ct Ste 200
EL DORADO HILLS, CA 95762 US
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Contact
PETER KOLLINGS
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Regulation Number
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Classification Product Code
PKP
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Date Received
08/20/2014
Decision Date
05/14/2015
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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