The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Hi Bebe Super (models Bt-150s And Bt-150l).
| Device ID | K200675 |
| 510k Number | K200675 |
| Device Name: | Hi Bebe Super (Models BT-150S And BT-150L) |
| Classification | Pump, Breast, Powered |
| Applicant | Bistos Co., Ltd. 7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu Seongnam-si, KR 13201 |
| Contact | Hae Sun Jeong |
| Correspondent | Dave Kim Mtech Group 7707 Fannin St. Ste 200 Houston, TX 77054 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-16 |
| Decision Date | 2021-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800012315036 | K200675 | 000 |
| 18800012315029 | K200675 | 000 |