The following data is part of a premarket notification filed by Cs Medical L.l.c. with the FDA for Cs Medical Td 200 Disinfector With Td-12 High-level Disinfectant, Cs Medical Td-12 High-level Disinfectant.
| Device ID | K192228 |
| 510k Number | K192228 |
| Device Name: | CS Medical TD 200 Disinfector With TD-12 High-level Disinfectant, CS Medical TD-12 High-level Disinfectant |
| Classification | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid |
| Applicant | CS Medical L.L.C. 2179 East Lyon Station Road Creedmoor, NC 27522 |
| Contact | Kendall Ashe |
| Correspondent | Kendall Ashe CS Medical L.L.C. 2179 East Lyon Station Road Creedmoor, NC 27522 |
| Product Code | PSW |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-16 |
| Decision Date | 2020-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B205CSTD2001 | K192228 | 000 |
| B205CSTD121 | K192228 | 000 |