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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 K974788
Device Name CRE(TM) BALLOON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Applicant Contact DANIEL J DILLION
Correspondent
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Correspondent Contact DANIEL J DILLION
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received12/22/1997
Decision Date 03/20/1998
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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