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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 K122717
Device Name FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
Applicant
TIGER MEDICAL PRODUCTS LTD
1 HUAIHAI ZHONG ROAD
LIU LIN TOWER, SUITE 1910
SHANGHAI,  CN 200021
Applicant Contact DAVID WANG
Correspondent
TIGER MEDICAL PRODUCTS LTD
1 HUAIHAI ZHONG ROAD
LIU LIN TOWER, SUITE 1910
SHANGHAI,  CN 200021
Correspondent Contact DAVID WANG
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/05/2012
Decision Date 12/21/2012
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
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