The following data is part of a premarket notification filed by Cenorin, Llc with the FDA for Cenorin 610 Washer-pasteurizers/high Level Disinfector And Cenorin 610ht Washer-pasteurizers/high Level Disinfector.
| Device ID | K183444 |
| 510k Number | K183444 |
| Device Name: | Cenorin 610 Washer-Pasteurizers/High Level Disinfector And Cenorin 610HT Washer-Pasteurizers/High Level Disinfector |
| Classification | Device, Pasteurization, Hot Water |
| Applicant | Cenorin, LLC 6324 South 199th Place Suite 107 Kent, WA 98032 |
| Contact | Jenette A. Bennett |
| Correspondent | Jenette A. Bennett Cenorin, LLC 6324 South 199th Place Suite 107 Kent, WA 98032 |
| Product Code | LDS |
| CFR Regulation Number | 880.6991 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-12 |
| Decision Date | 2019-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852494007085 | K183444 | 000 |
| 00852494007078 | K183444 | 000 |