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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 K854289
Device Name MEDSURG ULTRASOUND BIOPSY TRAY
Applicant
MEDSURG INDUSTRIES, INC.
251 EXCHANGE PLACE
HERNDON,  VA  20170 -4822
Applicant Contact DONNA DOLLIER
Correspondent
MEDSURG INDUSTRIES, INC.
251 EXCHANGE PLACE
HERNDON,  VA  20170 -4822
Correspondent Contact DONNA DOLLIER
Regulation Number876.1075
Classification Product Code
FCG  
Subsequent Product Code
MUI  
Date Received10/25/1985
Decision Date 11/26/1985
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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