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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 K904788
Device Name MEWISSEN CATHETER
Original Applicant
BOSTON SCIENTIFIC CORP.
2710 orchard pkwy.
san jose,  CA  95134
Original Contact jeanne lesniak
Regulation Number870.1200
Classification Product Code
DQO  
Date Received10/23/1990
Decision Date 12/17/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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