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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K912961
Device Name MORSE VASCULAR INTRODUCER SET
Applicant
North American Instrument Corp.
Glens Falls,  NY  12801
Applicant Contact MARLENE WRIGHT
Correspondent
North American Instrument Corp.
Glens Falls,  NY  12801
Correspondent Contact MARLENE WRIGHT
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/08/1991
Decision Date 09/11/1991
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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