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).
| Device ID | K133070 |
| 510k Number | K133070 |
| Device Name: | SURGICAL FACE MASK (Ear Loops And Tie-on) |
| Classification | Mask, Surgical |
| Applicant | B.H. MEDICAL PRODUCTS CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Leon Lu |
| Correspondent | Di Wu MEDEVICE CHINA, LTD. 12F WEIYA BUILDING, NO.29 SUZHOU STREET, HAIDIAN DISTRICT Beijing, CN 100080 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2015-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040169025 | 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 |
| 20816419020287 | K133070 | 000 |
| 20816419020270 | K133070 | 000 |
| 20816419020263 | 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 |
| D771252052FP0 | 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 |
| D77125205WH1 | K133070 | 000 |
| D77125205PK1 | K133070 | 000 |
| D77125205LV1 | 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 |