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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K141382
Device Name BIOS KING BIOCELLULOSE FILM
Applicant
Coreleader Biotech Co., Ltd.
19f # 100, Sec 1
Xintai 5th Rd., Xizhi Dist
New Taipei City,  TW 22102
Applicant Contact YA-WEN KUO
Correspondent
Coreleader Biotech Co., Ltd.
19f # 100, Sec 1
Xintai 5th Rd., Xizhi Dist
New Taipei City,  TW 22102
Correspondent Contact YA-WEN KUO
Classification Product Code
FRO  
Date Received05/27/2014
Decision Date 02/10/2015
Decision Substantially Equivalent (SESE)
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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