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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 K914732
Device Name CORE MEDICAL BIOPSY NEEDLE
Applicant
CORE MEDICAL, INC.
795 DAVIDSON DRIVE NORTH WEST
CONCORD,  NC  28025
Applicant Contact DONALD F RYAN
Correspondent
CORE MEDICAL, INC.
795 DAVIDSON DRIVE NORTH WEST
CONCORD,  NC  28025
Correspondent Contact DONALD F RYAN
Regulation Number876.1075
Classification Product Code
FCG  
Date Received10/21/1991
Decision Date 01/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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