Clearance Summary
HAWKINS MINI-E.B.A. received FDA 510(k) clearance under submission number K862031, sponsored by Pb Sales C/O Geller & Bozeman. 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 1986-07-14.
- Submission: K862031
- Applicant / Sponsor: Pb Sales C/O Geller & Bozeman
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1986-07-14
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.