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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, Polypropylene
510(k) Number K191299
Device Name Silhouette Featherlift / Silhouette Lift
Applicant
Silhouette Lift, Inc.
1 Technology Dr. F211
Irvine,  CA  92618
Applicant Contact Anthony DiBernardo
Correspondent
Silhouette Lift, Inc.
1 Technology Dr. F211
Irvine,  CA  92618
Correspondent Contact Anthony DiBernardo
Regulation Number878.5010
Classification Product Code
GAW  
Subsequent Product Code
GAM  
Date Received05/14/2019
Decision Date 06/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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