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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K873955
Device Name NAMIC ANGIOGRAPHIC SYRINGE
Applicant
North American Instrument Corp.
Glens Falls,  NY  12801
Applicant Contact EAMONN P HOBBS
Correspondent
North American Instrument Corp.
Glens Falls,  NY  12801
Correspondent Contact EAMONN P HOBBS
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/28/1987
Decision Date 02/05/1988
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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