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FDA 510(k) Application Details - K130906
Device Classification Name
System, Gastrointestinal Motility (Electrical)
More FDA Info for this Device
510(K) Number
K130906
Device Name
System, Gastrointestinal Motility (Electrical)
Applicant
CROSPON, LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134 US
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Contact
PAUL DRYDEN
Other 510(k) Applications for this Contact
Regulation Number
876.1725
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Classification Product Code
FFX
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More FDA Info for this Product Code
Date Received
04/01/2013
Decision Date
07/17/2013
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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