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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K902245
Device Name SONICATH(TM) 9F, 12 MHZ
Applicant
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Applicant Contact JEANNE M LESNIAK
Correspondent
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Correspondent Contact JEANNE M LESNIAK
Regulation Number892.1570
Classification Product Code
ITX  
Date Received05/18/1990
Decision Date 10/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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