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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 K181803
Device Name Medax Biopsy Systems III
Applicant
Medax Srl Unipersonale
Via R.Piva, 1/A
Poggio Rusco,  IT 46025
Applicant Contact Stefano Cavalieri
Correspondent
Coronati Consulting Srl
Via Luigi Gavioli, 3
Mirandola,  IT 41037
Correspondent Contact Serena Coronati
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/05/2018
Decision Date 10/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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