OLYMPIC PASTEURMATIC SYSTEM
FDA 510(k) clearance K953645 · decided 1995-09-22
Clearance details
- K-number
- K953645
- Device name
- OLYMPIC PASTEURMATIC SYSTEM
- Applicant
- Olympic Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-04
- Decision date
- 1995-09-22
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LDS
- Device class
- 2
- Regulation number
- 880.6991
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector (K183444) | Cenorin, LLC | 2019-09-09 |
| MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 (K031799) | Miele, Inc. | 2003-11-12 |
| RELIANCE FAMILY OF WASHER-DISINFECTORS (K983068) | STERIS Corporation | 2000-05-31 |
| OLYMPIX MINI-PASTEURMATIC (58210) (K972193) | Olympic Medical Corp. | 1997-09-05 |
| MIELE G 7781 DENTAL THERMAL DISINFECTOR (K950518) | Miele Professional | 1996-01-26 |
| DECOMAT 4656 (K950566) | Getinge Disinfection, Inc. | 1995-10-19 |
| MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. (K884151) | Miele Appliances, Inc. | 1989-05-16 |
| CASTLE 7538 FLOOR LOADING WASHER (K860263) | Castle Co. | 1986-03-05 |
| CASTLE 7515 UTENSIL/GLASSWARE WASHER (K844089) | Castle Co. | 1985-01-14 |
| STERI-VERS (K810311) | The Hilrad Co. | 1981-04-17 |
Recalls involving this device
No recalls on record reference this clearance.