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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K051426
Device Name CARLO SURGICAL GOWN
Applicant
Sofilm Technology Co., Ltd.
622 Sec. 3 Ankang Rd.
Hisntien City
Taipei County 231,  TW
Applicant Contact JEFFRY O STULL
Correspondent
Sofilm Technology Co., Ltd.
622 Sec. 3 Ankang Rd.
Hisntien City
Taipei County 231,  TW
Correspondent Contact JEFFRY O STULL
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/01/2005
Decision Date 08/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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