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FDA 510(k)

ProTEC-USA EZDoff Gown

K-Number: K210405 · 2021-12-15

ApplicantCadillac Products, Inc.
Decision Date2021-12-15
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ProTEC-USA EZDoff Gown is a medical device manufactured by Cadillac Products, Inc.. It received FDA 510(k) clearance on 2021-12-15 under approval number K210405. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProTEC-USA EZDoff Gown?

ProTEC-USA EZDoff Gown is a medical device that received FDA 510(k) clearance on 2021-12-15. It is manufactured by Cadillac Products, Inc.. The 510(k) number is K210405.

When was ProTEC-USA EZDoff Gown approved by the FDA?

ProTEC-USA EZDoff Gown received FDA 510(k) clearance on 2021-12-15, under approval number K210405.

What company makes ProTEC-USA EZDoff Gown?

ProTEC-USA EZDoff Gown is manufactured by Cadillac Products, Inc..

What is the FDA product code for ProTEC-USA EZDoff Gown?

The FDA product code for ProTEC-USA EZDoff Gown is QPC.

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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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