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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K090131
Device Name DS N95 SURGICAL MASKS AND FLAT SURGICAL
Applicant
Shanghai Dasheng Health Products
Songjiang District
Shanghai,  CN
Applicant Contact MAGGIE ZHONG
Correspondent
Shanghai Dasheng Health Products
Songjiang District
Shanghai,  CN
Correspondent Contact MAGGIE ZHONG
Regulation Number878.4040
Classification Product Code
MSH  
Subsequent Product Code
FXX  
Date Received01/21/2009
Decision Date 04/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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