ePTFE-Coated Auricular Implant
FDA 510(k) K172389 · Implantech Associates, Inc.
510(k) numberK172389
Submission
- Device name
- ePTFE-Coated Auricular Implant
- Applicant
- Implantech Associates, Inc.
Ventura, CA, US - Received
- August 8, 2017
- Decision date
- July 18, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FZD – Prosthesis, Ear, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3590
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code FZD
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Questions and answers
When was ePTFE-Coated Auricular Implant cleared by the FDA?
ePTFE-Coated Auricular Implant (K172389) received a 510(k) decision of Substantially Equivalent on July 18, 2018, 344 days after the submission was received.
What is the product code of K172389?
The FDA product code is FZD – Prosthesis, Ear, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3590.