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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 K211132
Device Name ARISTE AB Mesh
Ariste Medical LLC
9950 S 300 W
Sandy,  UT  84070
Applicant Contact Olaf Schulz
Health Policy Associates Inc
690 Canton Street, Suite 302
Westwood,  MA  02492
Correspondent Contact Brian Young
Regulation Number878.3300
Classification Product Code
Date Received04/16/2021
Decision Date 03/18/2022
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 Yes