The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympix Mini-pasteurmatic (58210).
| Device ID | K972193 |
| 510k Number | K972193 |
| Device Name: | OLYMPIX MINI-PASTEURMATIC (58210) |
| Classification | Device, Pasteurization, Hot Water |
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Contact | Joseph P Stefanile |
| Correspondent | Joseph P Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Product Code | LDS |
| CFR Regulation Number | 880.6991 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-10 |
| Decision Date | 1997-09-05 |
| Summary: | summary |