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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 K900652
Device Name NAMIC PTCA Y-ADAPTOR
Applicant
North American Instrument Corp.
Glens Falls,  NY  12801
Applicant Contact E FRANKLIN
Correspondent
North American Instrument Corp.
Glens Falls,  NY  12801
Correspondent Contact E FRANKLIN
Regulation Number870.4290
Classification Product Code
DTL  
Date Received02/09/1990
Decision Date 06/26/1990
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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