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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 K112580
Device Name COLLAGEN WOUND DRESSING
Applicant
Dalim Tissen Co., Ltd.
325 N. Puente St., Unit B
Brea,  CA  92821
Applicant Contact APRIL LEE
Correspondent
Dalim Tissen Co., Ltd.
325 N. Puente St., Unit B
Brea,  CA  92821
Correspondent Contact APRIL LEE
Classification Product Code
KGN  
Date Received09/06/2011
Decision Date 06/01/2012
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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