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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K031398
Device Name IS-1 HEMOSTASIS VALVE, MODEL 6799
Applicant
Guidant Corp.
4100 Hamline Ave., N.
St. Paul,  MN  55112 -5798
Applicant Contact Colleen McCarter Bloom
Correspondent
Guidant Corp.
4100 Hamline Ave., N.
St. Paul,  MN  55112 -5798
Correspondent Contact Colleen McCarter Bloom
Regulation Number870.4290
Classification Product Code
DTL  
Date Received05/05/2003
Decision Date 05/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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