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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 K050232
Device Name RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Applicant Contact PAIGE SWEENEY
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Correspondent Contact PAIGE SWEENEY
Regulation Number876.5980
Classification Product Code
PID  
Date Received02/01/2005
Decision Date 03/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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