Clearance Summary
R1124 & R1686 PARAFFIN received FDA 510(k) clearance under submission number K861344, sponsored by Tri W-G, Inc.. 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 1986-05-27.
- Submission: K861344
- Applicant / Sponsor: Tri W-G, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5110
- Decision date: 1986-05-27
Classification & Regulation
This clearance is catalogued under FDA product code IMC and 21 CFR 890.5110, within the Physical Medicine review panel as a Class II device.