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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, catheter, ureteral
510(k) Number K980795
Device Name UROLOGICAL BALLOON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact LINDA S POLLITZ
Correspondent
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact LINDA S POLLITZ
Regulation Number876.5470
Classification Product Code
EZN  
Subsequent Product Code
KOE  
Date Received03/02/1998
Decision Date 04/22/1998
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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