Clearance Summary
BECSIC COLLAR received FDA 510(k) clearance under submission number K820366, sponsored by Blackstone & Breglio Industries. 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 1982-03-01.
- Submission: K820366
- Applicant / Sponsor: Blackstone & Breglio Industries
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3490
- Decision date: 1982-03-01
Classification & Regulation
This clearance is catalogued under FDA product code IQK and 21 CFR 890.3490, within the Physical Medicine review panel as a Class I device.