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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser Absorbing Particles
510(k) Number K181518
Device Name Sebacia Microparticles
Applicant
Sebacia, Inc.
2905 Premiere Pkwy., Suite 150
Duluth,  GA  30097
Applicant Contact Todd J. Meyer
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number878.4810
Classification Product Code
QCY  
Subsequent Product Code
GEX  
Date Received06/08/2018
Decision Date 09/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT03303170
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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