The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing, Llc with the FDA for Standard Sterilizable Tray.
| Device ID | K202524 |
| 510k Number | K202524 |
| Device Name: | Standard 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 | 2020-09-01 |
| Decision Date | 2021-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307125860 | K202524 | 000 |
| 10841307125853 | K202524 | 000 |
| 10841307125846 | K202524 | 000 |
| 10841307125839 | K202524 | 000 |
| 10841307127765 | K202524 | 000 |
| 10841307127758 | K202524 | 000 |