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 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

NIH GUDID Devices

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