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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 K842829
Device Name HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS
Applicant
North American Instrument Corp.
Medical Products Div
Hudson Falls,  NY  12839
Applicant Contact PHILLIP H MORSE
Correspondent
North American Instrument Corp.
Medical Products Div
Hudson Falls,  NY  12839
Correspondent Contact PHILLIP H MORSE
Regulation Number870.4290
Classification Product Code
DTL  
Date Received07/20/1984
Decision Date 10/18/1984
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
Recalls CDRH Recalls
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