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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 -1537
Applicant Contact PAIGE SWEENEY
Correspondent
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
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
Recalls CDRH Recalls
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