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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K142061
Device Name SILHOUETTE INSTALIFT
Applicant
Silhouette Lift, Inc.
1 Technology Dr., Suite F211
Irvine,  CA  92618
Applicant Contact Juan Carlos Serna
Correspondent
Health Policy Associates, Inc.
690 Canton St., Suite 302
Canton,  MA  02090
Correspondent Contact Juan Carlos Serna
Regulation Number878.4493
Classification Product Code
GAM  
Date Received07/30/2014
Decision Date 04/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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