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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 K890676
Device Name DISPOSABLE TRANSDUCER MANIFOLD
Applicant
L.O.N. Research, Inc.
700 Bevier Rd.
Sanford,  FL  32771
Applicant Contact LOUIS O NOCE
Correspondent
L.O.N. Research, Inc.
700 Bevier Rd.
Sanford,  FL  32771
Correspondent Contact LOUIS O NOCE
Regulation Number870.4290
Classification Product Code
DTL  
Date Received02/09/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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