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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 K915078
Device Name MORSE HEMOSTATIC CATHETER INTRODUCER SET
Applicant
North American Instrument Corp.
Glens Falls,  NY  12801
Applicant Contact JAMES WELSH
Correspondent
North American Instrument Corp.
Glens Falls,  NY  12801
Correspondent Contact JAMES WELSH
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/08/1991
Decision Date 06/10/1992
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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