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FDA 510(k)

DESCRIBE PFD Patch

K-Number: K172689 · 2017-11-29

Decision Date2017-11-29
Product CodePKO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DESCRIBE PFD Patch is a medical device manufactured by Merz North America, Inc.. It received FDA 510(k) clearance on 2017-11-29 under approval number K172689. The device is classified under product code PKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DESCRIBE PFD Patch?

DESCRIBE PFD Patch is a medical device that received FDA 510(k) clearance on 2017-11-29. It is manufactured by Merz North America, Inc.. The 510(k) number is K172689.

When was DESCRIBE PFD Patch approved by the FDA?

DESCRIBE PFD Patch received FDA 510(k) clearance on 2017-11-29, under approval number K172689.

What company makes DESCRIBE PFD Patch?

DESCRIBE PFD Patch is manufactured by Merz North America, Inc..

What is the FDA product code for DESCRIBE PFD Patch?

The FDA product code for DESCRIBE PFD Patch is PKO.

Other Devices by Merz North America, Inc.

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.