The following data is part of a premarket notification filed by Bh Medical Products Co., Ltd. with the FDA for Bh Sterilization Pouch.
| Device ID | K172280 |
| 510k Number | K172280 |
| Device Name: | BH Sterilization Pouch |
| Classification | Wrap, Sterilization |
| Applicant | BH Medical Products Co., Ltd. No.90 Shenjiang Villagers Group, Zhangjiacunwei, Xilin Street Changzhou, CN 213024 |
| Contact | Edward Tao |
| Correspondent | Edward Tao BH Medical Products Co., Ltd. No.90 Shenjiang Villagers Group, Zhangjiacunwei, Xilin Street Changzhou, CN 213024 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-28 |
| Decision Date | 2018-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D832POH712135 | K172280 | 000 |
| D79011920020 | K172280 | 000 |
| D79011920010 | K172280 | 000 |
| 10816419022482 | K172280 | 000 |
| 20816419020416 | K172280 | 000 |
| 20816419020409 | K172280 | 000 |
| 20816419020393 | K172280 | 000 |
| 20816419020386 | K172280 | 000 |
| 20816419020379 | K172280 | 000 |
| 20816419020362 | K172280 | 000 |
| 20816419020355 | K172280 | 000 |
| D79011920030 | K172280 | 000 |
| D79011920040 | K172280 | 000 |
| D832POH514105 | K172280 | 000 |
| D832POH414125 | K172280 | 000 |
| D832POH31295 | K172280 | 000 |
| D832POH3125145 | K172280 | 000 |
| D832POH295 | K172280 | 000 |
| D832POH23495 | K172280 | 000 |
| D832POH21445 | K172280 | 000 |
| D832POH12155 | K172280 | 000 |
| D832POH10155 | K172280 | 000 |
| D79011920050 | K172280 | 000 |
| 20816419020348 | K172280 | 000 |