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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 K955554
Device Name HEMO-VALVE
Applicant
NORTH AMERICAN INSTRUMENT CORP.
PRUYNS ISLAND RD.
GLENS FALLS,  NY  12801
Applicant Contact MARY M RUBIN
Correspondent
NORTH AMERICAN INSTRUMENT CORP.
PRUYNS ISLAND RD.
GLENS FALLS,  NY  12801
Correspondent Contact MARY M RUBIN
Regulation Number870.4290
Classification Product Code
DTL  
Date Received12/05/1995
Decision Date 03/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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