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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K924271
Device Name CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES
Applicant
CORE MEDICAL, INC.
795 DAVIDSON DRIVE NORTH WEST
CONCORD,  NC  28025
Applicant Contact DON RYAN
Correspondent
CORE MEDICAL, INC.
795 DAVIDSON DRIVE NORTH WEST
CONCORD,  NC  28025
Correspondent Contact DON RYAN
Regulation Number876.1075
Classification Product Code
FCG  
Date Received08/24/1992
Decision Date 11/23/1992
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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