The following data is part of a premarket notification filed by Paragon Medical with the FDA for Sonopet Iq Sterilization Tray.
| Device ID | K190667 |
| 510k Number | K190667 |
| Device Name: | Sonopet IQ Sterilization Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Paragon Medical 8 Matchett Dr. Pierceton, IN 46562 |
| Contact | Rebecca Walker |
| Correspondent | Rebecca Walker Paragon Medical 8 Matchett Dr Pierceton, IN 46562 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-15 |
| Decision Date | 2019-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857387006497 | K190667 | 000 |