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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone, For Scar Management
510(k) Number K111733
Device Name CORELEADER SCAR-DIMMER
Applicant
Coreleader Biotech Co., Ltd.
19f # 100, Sec 1
Sintai 5th Rd., Sijhih Dist
New Taipei, Taiwan,  TW 22102
Applicant Contact IAN LI
Correspondent
Coreleader Biotech Co., Ltd.
19f # 100, Sec 1
Sintai 5th Rd., Sijhih Dist
New Taipei, Taiwan,  TW 22102
Correspondent Contact IAN LI
Regulation Number878.4025
Classification Product Code
MDA  
Date Received06/21/2011
Decision Date 09/22/2011
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
Predetermined Change
Control Plan Authorized		 No
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