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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K902472
Device Name MORSE DT MANIFOLD
Applicant
North American Instrument Corp.
Glens Falls,  NY  12801
Applicant Contact ROBERT E FRANKLIN
Correspondent
North American Instrument Corp.
Glens Falls,  NY  12801
Correspondent Contact ROBERT E FRANKLIN
Regulation Number870.2850
Classification Product Code
DRS  
Date Received06/04/1990
Decision Date 08/23/1990
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
Recalls CDRH Recalls
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