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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
Recalls CDRH Recalls
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