510(k) K172389
K172389 is an FDA 510(k) premarket notification submitted by Implantech Associates, Inc. for the device "ePTFE-Coated Auricular Implant". The FDA issued a decision of Substantially Equivalent on July 18, 2018. The device falls under product code FZD (Prosthesis, Ear, Internal), a Class II device regulated under 21 CFR 878.3590. Implantech Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2018
- Date Received
- August 8, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Ear, Internal
- Device Class
- Class II
- Regulation Number
- 878.3590
- Review Panel
- SU
- Submission Type