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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 K120997
Device Name BAROSTAT SOFTWARE OPTION
Original Applicant
CROSPON, LTD.
24301 woodsage drive
bonita springs,  FL  34134
Original Contact paul dryden
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/02/2012
Decision Date 08/27/2012
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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