Device Classification Name |
polymer, ent synthetic, porous polyethylene
|
510(k) Number |
K171037 |
Device Name |
PoreStar Patient Specific Implant |
Applicant |
Anatomics Pty Ltd |
23-27 Wellington St |
St Kilda,
AU
3182
|
|
Applicant Contact |
Joanne Flatley |
Correspondent |
Brandwood Biomedical |
Level 8, 1 Chandos St |
St Leonards,
AU
2065
|
|
Correspondent Contact |
Nicholas Connell |
Regulation Number | 874.3620
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/06/2017 |
Decision Date | 12/27/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|