K051819 is an FDA 510(k) clearance for the C CHANGE SOLUTION WARMER. This device is classified as a Warmer, Irrigation Solution (Class I - General Controls, product code LHC).
Submitted by C Change Surgical, LLC (Winston-Salem, US). The FDA issued a Cleared decision on August 15, 2005, 41 days after receiving the submission on July 5, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 890.5950.
| 510(k) Number | K051819 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2005 |
| Decision Date | August 15, 2005 |
| Days to Decision | 41 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 |