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FDA 510(k) Application Details - K160942
Device Classification Name
More FDA Info for this Device
510(K) Number
K160942
Device Name
Sonablate
Applicant
SonaCare Medical, LLC
10130 PERIMETER PARKWAY, SUITE 250
CHARLOTTE, NC 28216 US
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Contact
DAVID M. HERNON
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PLP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/05/2016
Decision Date
12/21/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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