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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 K000612
Device Name ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
Applicant
Inrad
3956 44th St., SE
Kentwood,  MI  49512
Applicant Contact JOSEPH M MAZUREK
Correspondent
Inrad
3956 44th St., SE
Kentwood,  MI  49512
Correspondent Contact JOSEPH M MAZUREK
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received02/23/2000
Decision Date 04/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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