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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 K090812
Device Name THERAFORM STANDARD/SHEET
Applicant
Sewon Cellontech Co., Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Applicant Contact JUNG BAE BANG
Correspondent
Sewon Cellontech Co., Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Correspondent Contact JUNG BAE BANG
Classification Product Code
KGN  
Date Received03/25/2009
Decision Date 07/30/2009
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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