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FDA 510(k) Application Details - K131096
Device Classification Name
Wound Cleaner, Ultrasound
More FDA Info for this Device
510(K) Number
K131096
Device Name
Wound Cleaner, Ultrasound
Applicant
AROBELLA MEDICAL, LLC
5929 BAKER ROAD
SUITE 470
MINNETONKA, MN 55345 US
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Contact
MATTHEW BERSCHEID
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Regulation Number
878.4410
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Classification Product Code
NRB
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More FDA Info for this Product Code
Date Received
04/18/2013
Decision Date
05/16/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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