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FDA 510(k) Application Details - K160725
Device Classification Name
System, Gastrointestinal Motility (Electrical)
More FDA Info for this Device
510(K) Number
K160725
Device Name
System, Gastrointestinal Motility (Electrical)
Applicant
CROSPON LTD.
GALWAY BUSINESS PARK, DANGAN
GALWAY IE
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Contact
JOHN O'DEA
Other 510(k) Applications for this Contact
Regulation Number
876.1725
More FDA Info for this Regulation Number
Classification Product Code
FFX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/16/2016
Decision Date
05/01/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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