The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Hi Bebe Plus.
| Device ID | K160274 |
| 510k Number | K160274 |
| Device Name: | Hi Bebe Plus |
| Classification | Pump, Breast, Powered |
| Applicant | BISTOS CO., LTD. 7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu Seongnam, KR 13201 |
| Contact | Jenny Cho |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-02 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887529000165 | K160274 | 000 |
| 00887529000151 | K160274 | 000 |
| 00887529000465 | K160274 | 000 |