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 |