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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 K902370
Device Name MODIFIED PROSTATIC URETHROPLASTY BALLOON 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 Received05/29/1990
Decision Date 08/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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