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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
Predetermined Change
Control Plan Authorized		 No
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