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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 K941853
Device Name PASSPORT
Applicant
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN,  MA  02472 -2407
Applicant Contact Lorraine M Hanley
Correspondent
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN,  MA  02472 -2407
Correspondent Contact Lorraine M Hanley
Regulation Number876.5470
Classification Product Code
EZN  
Date Received04/14/1994
Decision Date 09/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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