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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, biopsy
510(k) Number K160316
Device Name SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
Applicant
M.D.L. S.r.l.
Via Tavani 1/a
Delebio (So),  IT 23014
Applicant Contact Marcello Dell'Oca
Correspondent
Vantage Consulting International, Ltd.
888 E Belvidere Rd, Suite 212
Grayslake,  IL  60030
Correspondent Contact Barbara K Barbeau
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received02/05/2016
Decision Date 10/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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