Clearance Summary
SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL received FDA 510(k) clearance under submission number K791718, sponsored by Universal-Kundle Corp.. 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 1979-10-04.
- Submission: K791718
- Applicant / Sponsor: Universal-Kundle Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5100
- Decision date: 1979-10-04
Classification & Regulation
This clearance is catalogued under FDA product code ILJ and 21 CFR 890.5100, within the Physical Medicine review panel as a Class II device.