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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K981721
Device Name C0-AXIAL INTRODUCER NEEDLE
Applicant
Inrad
3956 44th St., SE
Kentwood,  MI  49512
Applicant Contact ANNE ARMSTRONG
Correspondent
Inrad
3956 44th St., SE
Kentwood,  MI  49512
Correspondent Contact ANNE ARMSTRONG
Regulation Number876.1075
Classification Product Code
KNW  
Date Received05/15/1998
Decision Date 07/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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