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FDA 510(k)

TK Insulin Syringe with/without Saftey Retractable Device

K-Number: K191639 · 2020-09-11

Decision Date2020-09-11
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TK Insulin Syringe with/without Saftey Retractable Device is a medical device manufactured by Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-09-11 under approval number K191639. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TK Insulin Syringe with/without Saftey Retractable Device?

TK Insulin Syringe with/without Saftey Retractable Device is a medical device that received FDA 510(k) clearance on 2020-09-11. It is manufactured by Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K191639.

When was TK Insulin Syringe with/without Saftey Retractable Device approved by the FDA?

TK Insulin Syringe with/without Saftey Retractable Device received FDA 510(k) clearance on 2020-09-11, under approval number K191639.

What company makes TK Insulin Syringe with/without Saftey Retractable Device?

TK Insulin Syringe with/without Saftey Retractable Device is manufactured by Anhui Tiankang Medical Technology Co., Ltd..

What is the FDA product code for TK Insulin Syringe with/without Saftey Retractable Device?

The FDA product code for TK Insulin Syringe with/without Saftey Retractable Device is MEG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.