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FDA 510(k) Application Details - K160130
Device Classification Name
More FDA Info for this Device
510(K) Number
K160130
Device Name
BloodSTOP iX Battle Matrix
Applicant
LifeSciencePLUS Inc.
2520A Wyandotte St.
Mountain View, CA 94043 US
Other 510(k) Applications for this Company
Contact
Audrey Vitale
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/20/2016
Decision Date
06/29/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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