The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Pasteurmatic, Models 3000 And 3500.
| Device ID | K081094 |
| 510k Number | K081094 |
| Device Name: | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 |
| Classification | Disinfector, Medical Devices |
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Contact | Steve Hesler |
| Correspondent | Steve Hesler OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Product Code | MEC |
| CFR Regulation Number | 880.6992 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-17 |
| Decision Date | 2008-06-20 |
| Summary: | summary |