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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophageal Dilator Balloon With Or Without Electrode Sensors
510(k) Number K132337
Device Name ESOFLIP BALLOON DILATION CATHETER
Applicant
Crospon, Ltd.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
Crospon, Ltd.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number876.5980
Classification Product Code
PID  
Subsequent Product Code
PIE  
Date Received07/26/2013
Decision Date 10/07/2013
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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