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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K904275
Device Name MORSE BALLOON INFLATION DEVICE
Applicant
North American Instrument Corp.
Glens Falls,  NY  12801
Applicant Contact ROBERT FRANKLIN
Correspondent
North American Instrument Corp.
Glens Falls,  NY  12801
Correspondent Contact ROBERT FRANKLIN
Regulation Number870.1650
Classification Product Code
MAV  
Date Received09/18/1990
Decision Date 01/03/1991
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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