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 |