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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 K961499
Device Name LAGUNA SOFTIP DIAGNOSTIC CATHETERS
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS,  MN  55442
Applicant Contact MARIA BRITTLE
Correspondent
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS,  MN  55442
Correspondent Contact MARIA BRITTLE
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/18/1996
Decision Date 10/17/1996
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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