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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 K960317
Device Name LAURUS NEEDLE CORE BIOPSY SYSTEM
Applicant
Laurus Medical Corp.
30 Hughes
Suite 202
Irvine,  CA  92718
Applicant Contact NORMAN S GORDON
Correspondent
Laurus Medical Corp.
30 Hughes
Suite 202
Irvine,  CA  92718
Correspondent Contact NORMAN S GORDON
Regulation Number876.1075
Classification Product Code
FCG  
Date Received01/23/1996
Decision Date 03/15/1996
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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