The following data is part of a premarket notification filed by Cimilre Co., Ltd. with the FDA for Cimlre F1 And Cimilre S3.
| Device ID | K162870 |
| 510k Number | K162870 |
| Device Name: | CIMLRE F1 And CIMILRE S3 |
| Classification | Pump, Breast, Powered |
| Applicant | CIMILRE CO., LTD. #201, 202, Sagimakgol-ro 148, Jungwon-gu Seongnam-si, KR 13207 |
| Contact | Ko Bong Jae |
| Correspondent | Ko Bong Jae CIMILRE CO., LTD. #201, 202, Sagimakgol-ro 148, Jungwon-gu Seongnam-si, KR 13207 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-13 |
| Decision Date | 2017-03-07 |
| Summary: | summary |