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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 K870073
Device Name MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
Applicant
Clinical Connections, Inc.
P.O. Box 238
9287 Smucker Rd.
Orrville,  OH  44667
Applicant Contact KEITH ANTAL
Correspondent
Clinical Connections, Inc.
P.O. Box 238
9287 Smucker Rd.
Orrville,  OH  44667
Correspondent Contact KEITH ANTAL
Regulation Number870.4290
Classification Product Code
DTL  
Date Received01/08/1987
Decision Date 02/20/1987
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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