TK Sterile Hypodermic Needle
K-Number: K191643 · 2019-12-19
Decision Date2019-12-19
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
TK Sterile Hypodermic Needle is a medical device manufactured by Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-19 under approval number K191643. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TK Sterile Hypodermic Needle?
TK Sterile Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K191643.
When was TK Sterile Hypodermic Needle approved by the FDA?
TK Sterile Hypodermic Needle received FDA 510(k) clearance on 2019-12-19, under approval number K191643.
What company makes TK Sterile Hypodermic Needle?
TK Sterile Hypodermic Needle is manufactured by Anhui Tiankang Medical Technology Co., Ltd..
What is the FDA product code for TK Sterile Hypodermic Needle?
The FDA product code for TK Sterile Hypodermic Needle is FMI.
Related Clinical Trials
Other Devices by Anhui Tiankang Medical Technology Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.