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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K230510
Device Name MyEllevate
Cynosure, LLC
5 Carlisle Road
Westford,  MA  01886
Applicant Contact Cynthia Aguirre
Cynosure, LLC
5 Carlisle Road
Westford,  MA  01886
Correspondent Contact Cynthia Aguirre
Regulation Number878.5000
Classification Product Code
Date Received02/24/2023
Decision Date 07/06/2023
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