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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 K023755
Device Name WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD
Applicant
WINNER INDUSTRIES (SHENZHEN) CO., LTD.
1900-H PROFORMA AVE.
ONTARIO,  CA  92861
Applicant Contact MING XIE
Correspondent
WINNER INDUSTRIES (SHENZHEN) CO., LTD.
1900-H PROFORMA AVE.
ONTARIO,  CA  92861
Correspondent Contact MING XIE
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/08/2002
Decision Date 06/10/2003
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
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