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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Esophageal
510(k) Number K061787
Device Name MAXFORCE TTS SINGLE-USE BALLOON DILATOR
Applicant
Boston Scientific Corp
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact WING NG
Correspondent
Boston Scientific Corp
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact WING NG
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received06/26/2006
Decision Date 09/21/2006
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
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