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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ligator, hemorrhoidal
510(k) Number K150718
Device Name Wi-3 HAL-RAR System
Applicant
AGENCY FOR MEDICAL INNOVATIONS GMBH
IM LETTEN 1
FELDKIRCH, VORARLBERG,  AT 6800
Applicant Contact Stefanie Hoellger
Correspondent
AcKnowledge Regulatory Strategies
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison C Komiyama
Regulation Number876.4400
Classification Product Code
FHN  
Subsequent Product Code
IYN  
Date Received03/19/2015
Decision Date 06/12/2015
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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