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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K883202
Device Name ULTRASONIC IMAGING CATHETER
Applicant
Boston Scientific Corp
2710 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact COUVILLON, JR
Correspondent
Boston Scientific Corp
2710 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact COUVILLON, JR
Regulation Number870.2870
Classification Product Code
DXO  
Date Received07/28/1988
Decision Date 11/23/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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