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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Urethral
510(k) Number K922349
Device Name DOWD(TM) II
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 Number876.5520
Classification Product Code
KOE  
Date Received05/19/1992
Decision Date 08/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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