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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 K092850
Device Name ENDOFLIP
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 Received09/16/2009
Decision Date 12/15/2009
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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