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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K871378
Device Name NAMIC SELDINGER INTRODUCER NEEDLE
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 Number870.1390
Classification Product Code
DRC  
Date Received04/07/1987
Decision Date 05/06/1987
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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