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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 K982077
Device Name SELECTOR DIAGNOSTIC CATHETER
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS,  MN  55442
Applicant Contact JANELL A COLLEY
Correspondent
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS,  MN  55442
Correspondent Contact JANELL A COLLEY
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/12/1998
Decision Date 08/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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