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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 K172344
Device Name Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
Applicant
MEDAX S.R.L. UNIPERSONALE
Via R. Piva 1/A
Poggio Rusco,  IT 46025
Applicant Contact Stefano Cavalieri
Correspondent
Gemar s.r.l.
Via G. Puccini 1
Medolla,  IT I-41036
Correspondent Contact Mario Gennari
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/02/2017
Decision Date 11/13/2017
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
Predetermined Change
Control Plan Authorized		 No
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