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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K102946
Device Name CORELEADER COLLA-PAD MODEL CS 03030
Applicant
Coreleader Biotech Co., Ltd.
19f # 100, Sec 1
Sintai 5th Rd., Sijhih City
Taipei, Taiwan,  TW 22102
Applicant Contact IAN LI
Correspondent
Coreleader Biotech Co., Ltd.
19f # 100, Sec 1
Sintai 5th Rd., Sijhih City
Taipei, Taiwan,  TW 22102
Correspondent Contact IAN LI
Classification Product Code
KGN  
Date Received10/04/2010
Decision Date 05/20/2011
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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