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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 K100971
Device Name ATEK SURGICAL GOWNS
Applicant
Hangzhou Atek Medical & Textile Co., Ltd.
1340 W Pennsylvania Ave.
San Diego,  CA  92103
Applicant Contact Glen Feye
Correspondent
Hangzhou Atek Medical & Textile Co., Ltd.
1340 W Pennsylvania Ave.
San Diego,  CA  92103
Correspondent Contact Glen Feye
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/08/2010
Decision Date 09/27/2010
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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