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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(k) Number K170134
Device Name Reperen Surgical Mesh
Applicant
IconLab Inc.
65 Enterprise
Aliso Viejo,  CA  92656
Applicant Contact Pavel Paul Artemow
Correspondent
Extomed, LLC
24261 Lysanda Drive
Mission Viejo,  CA  92691
Correspondent Contact Anil Bhalani
Regulation Number878.3300
Classification Product Code
FTL  
Date Received01/17/2017
Decision Date 08/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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