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
FDA 510(k) clearance K160921 · decided 2016-11-03
Clearance details
- K-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
- Applicant
- Cs Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-04-04
- Decision date
- 2016-11-03
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- PSW
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Creedmoor, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.