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FDA 510(k) Application Details - K142000
Device Classification Name
More FDA Info for this Device
510(K) Number
K142000
Device Name
ESOFLIP ES
Applicant
CROSPON, LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134 US
Other 510(k) Applications for this Company
Contact
PAUL DRYDEN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PIE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2014
Decision Date
09/25/2014
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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