The following data is part of a premarket notification filed by Beijing Fert Technology Co., Ltd with the FDA for Burette-type Infusion Sets For Single Use, Disposable Infusion Sets With Precision Filters, Disposable Infusion Set.
Device ID | K161898 |
510k Number | K161898 |
Device Name: | Burette-type Infusion Sets For Single Use, Disposable Infusion Sets With Precision Filters, Disposable Infusion Set |
Classification | Set, Administration, Intravascular |
Applicant | BEIJING FERT TECHNOLOGY CO., LTD NO.9, ZHANGGUOZHUANG VILLAGE, CHANGXINDIAN TOWN FENG TAI DISTRICT Beijing, CN 100072 |
Contact | Meng Zhang |
Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-11 |
Decision Date | 2017-03-08 |
Summary: | summary |