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FDA 510(k)

U&U Insulin Syringe with/without Safety Retractable Device

K-Number: K152808 · 2016-03-25

Decision Date2016-03-25
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

U&U Insulin Syringe with/without Safety Retractable Device is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K152808. 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 U&U Insulin Syringe with/without Safety Retractable Device?

U&U Insulin Syringe with/without Safety Retractable Device is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K152808.

When did U&U Insulin Syringe with/without Safety Retractable Device receive FDA 510(k) clearance?

U&U Insulin Syringe with/without Safety Retractable Device received FDA 510(k) clearance on 2016-03-25, under 510(k) number K152808.

Who is the listed applicant for U&U Insulin Syringe with/without Safety Retractable Device?

The FDA 510(k) record lists U&U Medical Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U&U Insulin Syringe with/without Safety Retractable Device?

The FDA product code for U&U Insulin Syringe with/without Safety Retractable Device is MEG.

Other records listing U&U Medical Technology Co, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MEG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.