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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 K760843
Device Name PALEY TRANSPARENT MANIFOLD
Applicant
Usci, Div. C.R. Bard, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Usci, Div. C.R. Bard, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4290
Classification Product Code
DTL  
Date Received10/14/1976
Decision Date 11/12/1976
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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