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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 K860291
Device Name TUBING CONNECTORS
Applicant
Biomedical Exports, Inc.
P.O. Box 453
The Lawyer House, 718 Main St.
Suisun,  CA  94585
Applicant Contact M. W MOONEY
Correspondent
Biomedical Exports, Inc.
P.O. Box 453
The Lawyer House, 718 Main St.
Suisun,  CA  94585
Correspondent Contact M. W MOONEY
Regulation Number870.4290
Classification Product Code
DTL  
Date Received01/28/1986
Decision Date 03/31/1986
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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