The following data is part of a premarket notification filed by Guangzhou Improve Medical Instruments Co., Ltd. with the FDA for Improsafe Blood Collection Set With Pre-attached Holder, Improvacuter Blood Collection Set Pre-attached Holder, Improsafe Blood Collection Set, Improvacuter Blood Collection Set, Improsafe Multi Sample Needle, Improsafe Multi Sample Needle (flashback.
Device ID | K153388 |
510k Number | K153388 |
Device Name: | IMPROSAFE Blood Collection Set With Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. NO. 102, KAIYUAN AVENUE, SCIENCE CITY GUANGZHOU ECO & TECH DEV DISTRICT Guangzhou, CN 510530 |
Contact | Bangfu Sun |
Correspondent | Dianna Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-23 |
Decision Date | 2016-06-07 |
Summary: | summary |