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

Needle, Hypodermic, Single Lumen

GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD.

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.

Pre-market Notification Details

Device IDK153388
510k NumberK153388
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
ClassificationNeedle, Hypodermic, Single Lumen
Applicant GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. NO. 102, KAIYUAN AVENUE, SCIENCE CITY GUANGZHOU ECO & TECH DEV DISTRICT Guangzhou,  CN 510530
ContactBangfu Sun
CorrespondentDianna Hong
MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai,  CN 200120
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-23
Decision Date2016-06-07
Summary:summary

NIH GUDID Devices

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