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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Flexible
510(k) Number K885168
Device Name RUBENSTEIN URETERAL STONE FRAGMENT BRUSH
Applicant
Boston Scientific Corp
480 Pleasant St.
P.O. Box 7407
Watertown,  MA  02272
Applicant Contact ALBERT P SEPRINSKI
Correspondent
Boston Scientific Corp
480 Pleasant St.
P.O. Box 7407
Watertown,  MA  02272
Correspondent Contact ALBERT P SEPRINSKI
Regulation Number876.4680
Classification Product Code
FGO  
Date Received12/13/1988
Decision Date 09/08/1989
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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