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 |