The following data is part of a premarket notification filed by Implantech Associates Inc. with the FDA for Eptfe-coated Auricular Implant.
| Device ID | K172389 |
| 510k Number | K172389 |
| Device Name: | EPTFE-Coated Auricular Implant |
| Classification | Prosthesis, Ear, Internal |
| Applicant | Implantech Associates Inc. 6025 Nicolle St., Suite B Ventura, CA 93003 |
| Contact | Craig Arthur |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | FZD |
| Subsequent Product Code | FWP |
| Subsequent Product Code | FZE |
| Subsequent Product Code | LZK |
| CFR Regulation Number | 878.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-08 |
| Decision Date | 2018-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724EPTFEAPB63R1 | K172389 | 000 |
| M724EPTFEABF58L1 | K172389 | 000 |
| M724EPTFEABF55R1 | K172389 | 000 |
| M724EPTFEABF55L1 | K172389 | 000 |
| M724EPTFEAAH63R1 | K172389 | 000 |
| M724EPTFEAAH63L1 | K172389 | 000 |
| M724EPTFEAAH61R1 | K172389 | 000 |
| M724EPTFEAAH61L1 | K172389 | 000 |
| M724EPTFEAAH58R1 | K172389 | 000 |
| M724EPTFEAAH58L1 | K172389 | 000 |
| M724EPTFEAAH55R1 | K172389 | 000 |
| M724EPTFEABF58R1 | K172389 | 000 |
| M724EPTFEABF61L1 | K172389 | 000 |
| M724EPTFEAPB63L1 | K172389 | 000 |
| M724EPTFEAPB61R1 | K172389 | 000 |
| M724EPTFEAPB61L1 | K172389 | 000 |
| M724EPTFEAPB58R1 | K172389 | 000 |
| M724EPTFEAPB58L1 | K172389 | 000 |
| M724EPTFEAPB55R1 | K172389 | 000 |
| M724EPTFEAPB55L1 | K172389 | 000 |
| M724EPTFEABF63R1 | K172389 | 000 |
| M724EPTFEABF63L1 | K172389 | 000 |
| M724EPTFEABF61R1 | K172389 | 000 |
| M724EPTFEAAH55L1 | K172389 | 000 |