LDS — Device, Pasteurization, Hot Water Class II
FDA product code LDS covers "Device, Pasteurization, Hot Water", a Class II medical device regulated under 21 CFR 880.6991. Submissions are reviewed by the General Hospital panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LDS
- Device Class
- Class II
- Regulation Number
- 880.6991
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K183444 | cenorin | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer- | September 9, 2019 |
| K031799 | miele | MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 | November 12, 2003 |
| K983068 | steris corporation | RELIANCE FAMILY OF WASHER-DISINFECTORS | May 31, 2000 |
| K972193 | olympic medical | OLYMPIX MINI-PASTEURMATIC (58210) | September 5, 1997 |
| K950518 | miele professional | MIELE G 7781 DENTAL THERMAL DISINFECTOR | January 26, 1996 |
| K950566 | getinge disinfection | DECOMAT 4656 | October 19, 1995 |
| K953645 | olympic medical | OLYMPIC PASTEURMATIC SYSTEM | September 22, 1995 |
| K884151 | miele appliances | MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. | May 16, 1989 |
| K860263 | castle | CASTLE 7538 FLOOR LOADING WASHER | March 5, 1986 |
| K844089 | castle | CASTLE 7515 UTENSIL/GLASSWARE WASHER | January 14, 1985 |
| K810311 | hilrad | STERI-VERS | April 17, 1981 |