The following data is part of a premarket notification filed by Anatomics Pty, Ltd. with the FDA for Starpore.
| Device ID | K200532 |
| 510k Number | K200532 |
| Device Name: | StarPore |
| Classification | Polymer, Ent Synthetic, Porous Polyethylene |
| Applicant | Anatomics Pty, Ltd. Warehouse 1, 246 East Boundary Road Bentleigh East, AU 3165 |
| Contact | Christine Scifert |
| Correspondent | Christine Scifert Anatomics Pty, Ltd. Warehouse 1, 246 East Boundary Road Bentleigh East, AU 3165 |
| Product Code | JOF |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-06-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STARPORE 88418356 not registered Live/Pending |
Scimotana Pty. Ltd. 2019-05-07 |