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FDA 510(k) Application Details - K123822
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K123822
Device Name
Pump, Infusion
Applicant
HK SURGICAL, INC.
1271 PUERTA DEL SOL
SAN CLEMENTE, CA 92673 US
Other 510(k) Applications for this Company
Contact
CLARE BENNETT
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
FRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/2012
Decision Date
09/27/2013
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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