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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Needle, Surgical
510(k) Number K924270
Device Name BREAST LESION LOCALIZATION NEEDLE
Applicant
Core Medical, Inc.
795 Davidson Dr. N. W.
Concord,  NC  28025
Applicant Contact DON RYAN
Correspondent
Core Medical, Inc.
795 Davidson Dr. N. W.
Concord,  NC  28025
Correspondent Contact DON RYAN
Regulation Number878.4800
Classification Product Code
GDF  
Date Received08/24/1992
Decision Date 09/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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