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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 K022967
Device Name SUILE WOUND DRESSING
Applicant
Hedonist Biochemical Technologies Co., Ltd.
6833 Saint Lawrence St.
Plano,  TX  75024
Applicant Contact ERIC LUO
Correspondent
Hedonist Biochemical Technologies Co., Ltd.
6833 Saint Lawrence St.
Plano,  TX  75024
Correspondent Contact ERIC LUO
Classification Product Code
FRO  
Date Received09/06/2002
Decision Date 07/08/2003
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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