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FDA 510(k)

ePTFE-Coated Auricular Implant

K-Number: K172389 · 2018-07-18

ApplicantImplantech Associates, Inc.
Decision Date2018-07-18
Product CodeFZD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ePTFE-Coated Auricular Implant is a medical device manufactured by Implantech Associates, Inc.. It received FDA 510(k) clearance on 2018-07-18 under approval number K172389. The device is classified under product code FZD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ePTFE-Coated Auricular Implant?

ePTFE-Coated Auricular Implant is a medical device that received FDA 510(k) clearance on 2018-07-18. It is manufactured by Implantech Associates, Inc.. The 510(k) number is K172389.

When was ePTFE-Coated Auricular Implant approved by the FDA?

ePTFE-Coated Auricular Implant received FDA 510(k) clearance on 2018-07-18, under approval number K172389.

What company makes ePTFE-Coated Auricular Implant?

ePTFE-Coated Auricular Implant is manufactured by Implantech Associates, Inc..

What is the FDA product code for ePTFE-Coated Auricular Implant?

The FDA product code for ePTFE-Coated Auricular Implant is FZD.

Related Clinical Trials

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Other Devices by Implantech Associates, Inc.

K191130Customized Contour Implant K200610Customized Contour Implant

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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