K080609 is an FDA 510(k) clearance for the SWC/DWC WARMING CABINETS. This device is classified as a Warmer, Irrigation Solution (Class I - General Controls, product code LHC).
Submitted by Mac Medical (Deer Field, US). The FDA issued a Cleared decision on June 13, 2008, 102 days after receiving the submission on March 3, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 890.5950.
| 510(k) Number | K080609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2008 |
| Decision Date | June 13, 2008 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHC — Warmer, Irrigation Solution |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5950 |