The following data is part of a premarket notification filed by Caldera Medical, Inc with the FDA for Benesta Medical Sterilization Tray.
| Device ID | K193603 |
| 510k Number | K193603 |
| Device Name: | Benesta Medical Sterilization Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Caldera Medical, Inc 5171 Clareton Drive Agoura Hills, CA 91301 |
| Contact | Vicki Gail |
| Correspondent | Vicki Gail Caldera Medical, Inc 5171 Clareton Drive Agoura Hills, CA 91301 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857492008133 | K193603 | 000 |
| 00857492008065 | K193603 | 000 |