SURGICAL MASKS

Mask, Surgical

SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.

The following data is part of a premarket notification filed by Shanghai Neo-medical Import & Export Co., Ltd. with the FDA for Surgical Masks.

Pre-market Notification Details

Device IDK111559
510k NumberK111559
Device Name:SURGICAL MASKS
ClassificationMask, Surgical
Applicant SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. P.O. BOX 237-023 Shanghai,  CN 200237
ContactDiana Hong
CorrespondentDiana Hong
SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. P.O. BOX 237-023 Shanghai,  CN 200237
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-06
Decision Date2011-09-16

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