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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K895542
Device Name SONICATH(TM) 5 F
Applicant
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Applicant Contact ALFRED COUVILLON
Correspondent
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Correspondent Contact ALFRED COUVILLON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/13/1989
Decision Date 04/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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