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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 K102713
Device Name TIGER FLAT SURGICAL MASK
Applicant
Tiger Medical Products, Ltd.
Liulin Tower, Suite 1910,
1 Huai Hai Zhong Rd.
Shanghai,  CN 200021
Applicant Contact MAGGIE ZHONG
Correspondent
Tiger Medical Products, Ltd.
Liulin Tower, Suite 1910,
1 Huai Hai Zhong Rd.
Shanghai,  CN 200021
Correspondent Contact MAGGIE ZHONG
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/20/2010
Decision Date 01/25/2011
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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