The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Southern Implants Instrument Trays.
| Device ID | K210923 |
| 510k Number | K210923 |
| Device Name: | Southern Implants Instrument Trays |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Southern Implants (Pty) Ltd 1 Albert Road Irene, ZA 0062 |
| Contact | Lauranda G Breytenbach |
| Correspondent | Leith Cumming Southern Implants (Pty) Ltd 1 Albert Road Irene, ZA 0062 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2022-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544027348 | K210923 | 000 |
| 06009544044123 | K210923 | 000 |
| 06009544044130 | K210923 | 000 |
| 06009544045380 | K210923 | 000 |
| 06009544045458 | K210923 | 000 |
| 06009544033660 | K210923 | 000 |
| 06009544010739 | K210923 | 000 |
| 06009544011088 | K210923 | 000 |
| 06009544012092 | K210923 | 000 |
| 06009544012108 | K210923 | 000 |
| 06009544012429 | K210923 | 000 |
| 06009544012856 | K210923 | 000 |
| 06009544013631 | K210923 | 000 |
| 06009544044116 | K210923 | 000 |