Device Classification Name |
prosthesis, ear, internal
|
510(k) Number |
K172389 |
Device Name |
ePTFE-Coated Auricular Implant |
Applicant |
Implantech Associates Inc. |
6025 Nicolle St., Suite B |
Ventura,
CA
93003
|
|
Applicant Contact |
Craig Arthur |
Correspondent |
AcKnowledge Regulatory Strategies, LLC |
2834 Hawthorn St. |
San Diego,
CA
92104
|
|
Correspondent Contact |
Allison Komiyama |
Regulation Number | 878.3590
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/08/2017 |
Decision Date | 07/18/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|