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FDA 510(k) Application Details - K160198
Device Classification Name
Lithotriptor, Electro-Hydraulic
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510(K) Number
K160198
Device Name
Lithotriptor, Electro-Hydraulic
Applicant
Med-Sonics Corp
4960 Pittsburgh Avenue Suite A
Erie, PA 16509 US
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Contact
Jennifer Rautine
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Regulation Number
876.4480
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Classification Product Code
FFK
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More FDA Info for this Product Code
Date Received
01/28/2016
Decision Date
02/23/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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