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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K162445
Device Name LiVac Retractor System
Applicant
Livac Pty Ltd
8 Melaleuca Court
Warrnambool,  AU 3280
Applicant Contact Anabela Correia
Correspondent
Emergo Global
2500 Bee Cave, Bldg 1, Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/31/2016
Decision Date 10/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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