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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, Mechanical
510(k) Number K902124
Device Name DOWD CATHETER
Applicant
Boston Scientific Corp
480 Pleasant St.
P.O. Box 7407
Watertown,  MA  02272
Applicant Contact LEO L BASTA
Correspondent
Boston Scientific Corp
480 Pleasant St.
P.O. Box 7407
Watertown,  MA  02272
Correspondent Contact LEO L BASTA
Regulation Number876.5520
Classification Product Code
FAH  
Date Received05/11/1990
Decision Date 08/09/1990
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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