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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
Original Applicant
TIGER MEDICAL PRODUCTS LTD
1 huaihai zhong road
liu lin tower, suite 1910
shanghai,  CN 200021
Original 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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