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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
Device Name ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
Applicant
INRAD INC.
4375 DONKER CT SE
GRAND RAPIDS,  MI  49504
Applicant Contact RYAN GOOSEN
Correspondent
INRAD INC.
4375 DONKER CT SE
GRAND RAPIDS,  MI  49504
Correspondent Contact RYAN GOOSEN
Regulation Number876.1075
Classification Product Code
KNW  
Date Received10/04/2011
Decision Date 11/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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