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FDA 510(k)

REST EAZY Appliance

K-Number: K172760 · 2018-03-26

Decision Date2018-03-26
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REST EAZY Appliance is a medical device manufactured by Insert Molding Solutions, Inc.. It received FDA 510(k) clearance on 2018-03-26 under approval number K172760. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REST EAZY Appliance?

REST EAZY Appliance is a medical device that received FDA 510(k) clearance on 2018-03-26. It is manufactured by Insert Molding Solutions, Inc.. The 510(k) number is K172760.

When was REST EAZY Appliance approved by the FDA?

REST EAZY Appliance received FDA 510(k) clearance on 2018-03-26, under approval number K172760.

What company makes REST EAZY Appliance?

REST EAZY Appliance is manufactured by Insert Molding Solutions, Inc..

What is the FDA product code for REST EAZY Appliance?

The FDA product code for REST EAZY Appliance is LRK.

Related Devices (Code: LRK)

Official Source

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