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FDA 510(k)

Comfort Cover

K-Number: K161920 · 2016-07-15

ApplicantPrecision Dynamics Corporation
Decision Date2016-07-15
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Comfort Cover is a medical device manufactured by Precision Dynamics Corporation. It received FDA 510(k) clearance on 2016-07-15 under approval number K161920. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comfort Cover?

Comfort Cover is a medical device that received FDA 510(k) clearance on 2016-07-15. It is manufactured by Precision Dynamics Corporation. The 510(k) number is K161920.

When was Comfort Cover approved by the FDA?

Comfort Cover received FDA 510(k) clearance on 2016-07-15, under approval number K161920.

What company makes Comfort Cover?

Comfort Cover is manufactured by Precision Dynamics Corporation.

What is the FDA product code for Comfort Cover?

The FDA product code for Comfort Cover is IZH.

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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.

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