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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, gastrointestinal motility (electrical)
510(k) Number K130906
Device Name ENDOFLIP CATHETER
Applicant
CROSPON, LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
CROSPON, LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/01/2013
Decision Date 07/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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