The following data is part of a premarket notification filed by Cs Medical Llc with the FDA for Cs-medical Td 100 Disinfector With Td-5 And Td-8 High Level Disinfectants, Cs Medical Td-5 High Level Disinfectant, Cs Medical Td-8 High Level Disinfectant.
| Device ID | K160921 |
| 510k Number | K160921 |
| Device Name: | CS-Medical TD 100 Disinfector With TD-5 And TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant |
| Classification | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid |
| Applicant | CS Medical LLC 2179 East Lyon Station Road Creedmoor, NC 27522 |
| Contact | Kendall Ashe |
| Correspondent | Kendall Ashe CS Medical LLC 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 | 2016-04-04 |
| Decision Date | 2016-11-03 |
| Summary: | summary |