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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 K800416
Device Name ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)
Applicant
A.D.T. LAB INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
A.D.T. LAB INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1075
Classification Product Code
FCG  
Date Received02/26/1980
Decision Date 03/25/1980
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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