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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 K060776
Device Name SURGICAL FACE MASK
Applicant
Hong YA Non-Woven Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Applicant Contact KATHY LIU
Correspondent
Hong YA Non-Woven Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Correspondent Contact KATHY LIU
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/22/2006
Decision Date 05/25/2006
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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