FDA 510(k) Application Details - K160130

Device Classification Name

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510(K) Number K160130
Device Name BloodSTOP iX Battle Matrix
Applicant LifeSciencePLUS Inc.
2520A Wyandotte St.
Mountain View, CA 94043 US
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Contact Audrey Vitale
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Regulation Number

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Classification Product Code QSY
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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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