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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 K992906
Device Name COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
Applicant
Olson Medical Sales, Inc.
2101 Cottontail Ln.
Somerset,  NJ  08873
Applicant Contact GARRY A COURTNEY
Correspondent
Olson Medical Sales, Inc.
2101 Cottontail Ln.
Somerset,  NJ  08873
Correspondent Contact GARRY A COURTNEY
Regulation Number870.4290
Classification Product Code
DTL  
Date Received08/30/1999
Decision Date 11/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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