The following data is part of a premarket notification filed by Bh Medical Products Co., Ltd. with the FDA for Bh Medical Dental Barrier Sleeves And Barrier Film.
| Device ID | K190484 |
| 510k Number | K190484 |
| Device Name: | BH Medical Dental Barrier Sleeves And Barrier Film |
| Classification | Dental Barriers And Sleeves |
| Applicant | BH Medical Products Co., Ltd. No.90 Shenjiang Villagers' Group, Zhangjiacunwei, Xilin Street, Zhonglou District Changzhou, CN 213024 |
| Contact | Xiaohua Tao |
| Correspondent | Xiaohua Tao BH Medical Products Co., Ltd. No.90 Shenjiang Villagers' Group, Zhangjiacunwei, Xilin Street, Zhonglou District Changzhou, CN 213024 |
| Product Code | PEM |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-27 |
| Decision Date | 2019-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D79010845020 | K190484 | 000 |
| 20816419021994 | K190484 | 000 |
| 20816419021987 | K190484 | 000 |
| 20816419021970 | K190484 | 000 |
| 20816419021963 | K190484 | 000 |
| 20816419021956 | K190484 | 000 |
| 20816419021949 | K190484 | 000 |
| 20816419021871 | K190484 | 000 |
| 20816419021864 | K190484 | 000 |
| 20816419021857 | K190484 | 000 |
| 20816419021628 | K190484 | 000 |
| 20816419022007 | K190484 | 000 |
| 20816419022014 | K190484 | 000 |
| 20816419022021 | K190484 | 000 |
| D79010845010 | K190484 | 000 |
| D79010844010 | K190484 | 000 |
| D79010843010 | K190484 | 000 |
| D79010842010 | K190484 | 000 |
| D79010841010 | K190484 | 000 |
| 20816419022076 | K190484 | 000 |
| 20816419022069 | K190484 | 000 |
| 20816419022052 | K190484 | 000 |
| 20816419022045 | K190484 | 000 |
| 20816419022038 | K190484 | 000 |
| 20816419021611 | K190484 | 000 |