Clearance Summary
C CHANGE SOLUTION WARMER received FDA 510(k) clearance under submission number K051819, sponsored by C Change Surgical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2005-08-15.
- Submission: K051819
- Applicant / Sponsor: C Change Surgical, LLC
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5950
- Decision date: 2005-08-15
Classification & Regulation
This clearance is catalogued under FDA product code LHC and 21 CFR 890.5950, within the Physical Medicine review panel as a Class I device.