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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K003362
Device Name ASTRONOMER+WITH SLD
Original Applicant
BOSTON SCIENTIFIC CORP.
2710 orchard pkwy.
san jose,  CA  95134
Original Contact andrea j boumis
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/27/2000
Decision Date 03/01/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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