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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 K111559
Device Name SURGICAL MASKS
Original Applicant
SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.
p.o. box 237-023
shanghai,  CN 200237
Original Contact diana hong
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/06/2011
Decision Date 09/16/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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