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FDA 510(k)

SureStrip Vitrification Straw, SureLock Vitrification Straw

K-Number: K203626 · 2021-06-04

Decision Date2021-06-04
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SureStrip Vitrification Straw, SureLock Vitrification Straw is a medical device manufactured by Allwin Medical Devices, Inc.. It received FDA 510(k) clearance on 2021-06-04 under approval number K203626. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SureStrip Vitrification Straw, SureLock Vitrification Straw?

SureStrip Vitrification Straw, SureLock Vitrification Straw is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by Allwin Medical Devices, Inc.. The 510(k) number is K203626.

When was SureStrip Vitrification Straw, SureLock Vitrification Straw approved by the FDA?

SureStrip Vitrification Straw, SureLock Vitrification Straw received FDA 510(k) clearance on 2021-06-04, under approval number K203626.

What company makes SureStrip Vitrification Straw, SureLock Vitrification Straw?

SureStrip Vitrification Straw, SureLock Vitrification Straw is manufactured by Allwin Medical Devices, Inc..

What is the FDA product code for SureStrip Vitrification Straw, SureLock Vitrification Straw?

The FDA product code for SureStrip Vitrification Straw, SureLock Vitrification Straw is MQK.

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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.