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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 K112945
Model 931018,931518,932018,941018,941518
Device Name ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
Original Applicant
INRAD INC.
4375 donker ct se
grand rapids,  MI  49504
Original Contact ryan goosen
Regulation Number876.1075
Classification Product Code
KNW  
Date Received10/04/2011
Decision Date 11/03/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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