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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 K981166
Device Name ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214
Applicant
INRAD
3956 44TH ST., S.E.
KENTWOOD,  MI  49512
Applicant Contact ANNE ARMSTRONG
Correspondent
INRAD
3956 44TH ST., S.E.
KENTWOOD,  MI  49512
Correspondent Contact ANNE ARMSTRONG
Regulation Number876.1075
Classification Product Code
KNW  
Date Received03/31/1998
Decision Date 06/22/1998
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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