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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 K040776
Device Name ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975
Original Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont,  CA  94538 -6515
Original Contact robert z phillips
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/26/2004
Decision Date 04/29/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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