The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing, Llc with the FDA for Mini Sterilizable Tray.
| Device ID | K200858 |
| 510k Number | K200858 |
| Device Name: | Mini Sterilizable Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362 |
| Contact | Reina Choi |
| Correspondent | Reina Choi Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-01 |
| Decision Date | 2020-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307125891 | K200858 | 000 |
| 10841307125822 | K200858 | 000 |
| 10841307125815 | K200858 | 000 |
| 10841307125808 | K200858 | 000 |
| 10841307125792 | K200858 | 000 |
| 10841307125341 | K200858 | 000 |
| 10841307125334 | K200858 | 000 |
| 10841307125310 | K200858 | 000 |
| 10841307125303 | K200858 | 000 |