K953645 is an FDA 510(k) clearance for the OLYMPIC PASTEURMATIC SYSTEM. This device is classified as a Device, Pasteurization, Hot Water (Class II - Special Controls, product code LDS).
Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on September 22, 1995, 49 days after receiving the submission on August 4, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6991.
| 510(k) Number | K953645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1995 |
| Decision Date | September 22, 1995 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LDS — Device, Pasteurization, Hot Water |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6991 |