SURGICAL FACE MASK (Ear Loops And Tie-on)

Mask, Surgical

B.H. MEDICAL PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by B.h. Medical Products Co., Ltd. with the FDA for Surgical Face Mask (ear Loops And Tie-on).

Pre-market Notification Details

Device IDK133070
510k NumberK133070
Device Name:SURGICAL FACE MASK (Ear Loops And Tie-on)
ClassificationMask, Surgical
Applicant B.H. MEDICAL PRODUCTS CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover,  DE  19901
ContactLeon Lu
CorrespondentDi Wu
MEDEVICE CHINA, LTD. 12F WEIYA BUILDING, NO.29 SUZHOU STREET, HAIDIAN DISTRICT Beijing,  CN 100080
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-30
Decision Date2015-06-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20816419020775 K133070 000
20816419020287 K133070 000
20816419020294 K133070 000
20816419020300 K133070 000
20816419020317 K133070 000
20816419020324 K133070 000
20816419020331 K133070 000
20816419023080 K133070 000
10304040165246 K133070 000
50732224000386 K133070 000
50732224120503 K133070 000
D832MK110N2 K133070 000
D832MK1112 K133070 000
D832MK16N2 K133070 000
D832MK310L2 K133070 000
D832MK342 K133070 000
20816419020270 K133070 000
20816419020263 K133070 000
00304040169025 K133070 000
00304040169032 K133070 000
00304040169049 K133070 000
00304040165256 K133070 000
00304040165263 K133070 000
00304040168486 K133070 000
00304040168493 K133070 000
20816419020003 K133070 000
20816419020010 K133070 000
20816419020027 K133070 000
20816419020034 K133070 000
20816419020041 K133070 000
20816419020058 K133070 000
20816419020249 K133070 000
20816419020256 K133070 000
D832MK362 K133070 000
D832MKH322 K133070 000
D77125205WH1 K133070 000
D832MK115 K133070 000
D832MK1101 K133070 000
D832MK125 K133070 000
D832MK135 K133070 000
D832MK145 K133070 000
D832MK165 K133070 000
D832MK265 K133070 000
D832MK325 K133070 000
D832MKS125 K133070 000
D832MKS165 K133070 000
D832MKS325 K133070 000
D832MK225 K133070 000
20889215858941 K133070 000
00616784220239 K133070 000
D77125205PK1 K133070 000
D77125205LV1 K133070 000
D771252052FP0 K133070 000
D771252052PU0 K133070 000
D771252053BK0 K133070 000
D771252053BL0 K133070 000
D771252053CB0 K133070 000
D771252053OR0 K133070 000
D771252053PK0 K133070 000
D771252053PU0 K133070 000
D771252053WH0 K133070 000
D77125205BK0 K133070 000
D682GCSA29 K133070 000
D682GCABL2D K133070 000
D682GCAPK2Q K133070 000
D77125205BL1 K133070 000
D77125205GR1 K133070 000
00616784220628 K133070 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.