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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 K181756
Device Name Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
Applicant
AprioMed AB
Virdings Alle 28
Uppsala,  SE 75450
Applicant Contact Katrin Svensson
Correspondent
AprioMed AB
Virdings Alle 28
Uppsala,  SE 75450
Correspondent Contact Katrin Svensson
Regulation Number876.1075
Classification Product Code
FCG  
Date Received07/02/2018
Decision Date 12/18/2018
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
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