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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, disposable
510(k) Number K864800
Device Name NAMIC CHIBA ASPIRATION BIOPSY 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 Number878.4800
Classification Product Code
GAA  
Date Received12/09/1986
Decision Date 02/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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