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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 K854404
Device Name ROTEX SCREW BIOPSY NEEDLE
Applicant
MEADOX SURGIMED, INC.
112 BAUER DR.
OAKLAND,  NJ  07436
Applicant Contact SCOTT MINDREBO
Correspondent
MEADOX SURGIMED, INC.
112 BAUER DR.
OAKLAND,  NJ  07436
Correspondent Contact SCOTT MINDREBO
Regulation Number876.1075
Classification Product Code
FCG  
Date Received11/01/1985
Decision Date 12/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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