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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 K092338
Device Name MEDAX UNIPERSONALE SRL
Applicant
Medax Unipersonale Srl
3016 NW 82nd Ave.
Doral,  FL  33122
Applicant Contact FLAVIO TOMASSINI
Correspondent
Medax Unipersonale Srl
3016 NW 82nd Ave.
Doral,  FL  33122
Correspondent Contact FLAVIO TOMASSINI
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/04/2009
Decision Date 05/27/2011
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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