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FDA 510(k) Application Details - K171796
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K171796
Device Name
Set, I.V. Fluid Transfer
Applicant
Medimop Medical Project Ltd.
17 Hatidhar St
Ra'anana 43665 IL
Other 510(k) Applications for this Company
Contact
Jeffrey Ravel
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
LHI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2017
Decision Date
10/12/2017
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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