Clearance Summary
INTRATEMP SOLUTION WARMER received FDA 510(k) clearance under submission number K083417, 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 2009-01-13.
- Submission: K083417
- 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: 2009-01-13
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.