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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K101000
Device Name WELLMIEN SURGICAL MASK
Applicant
Wellmien (Suzhou) Import & Export Trading Co., Ltd.
Pennington,  NJ  08534
Applicant Contact CHENGYU SHEN
Correspondent
Wellmien (Suzhou) Import & Export Trading Co., Ltd.
Pennington,  NJ  08534
Correspondent Contact CHENGYU SHEN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/12/2010
Decision Date 08/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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