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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
Applicant
Ariste Medical, LLC
9950 S 300 W
Sandy,  UT  84070
Applicant Contact Olaf Schulz
Correspondent
Health Policy Associates, Inc.
690 Canton St., Suite 302
Westwood,  MA  02492
Correspondent Contact Brian Young
Regulation Number878.3300
Classification Product Code
FTL  
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
Predetermined Change
Control Plan Authorized		 No
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