Clearance Summary
REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 received FDA 510(k) clearance under submission number K013328, sponsored by Remington Products Company, 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 2001-12-03.
- Submission: K013328
- Applicant / Sponsor: Remington Products Company, LLC
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5110
- Decision date: 2001-12-03
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.