Clearance Summary
PROTECTIVE RESTRAINT received FDA 510(k) clearance under submission number K110377, sponsored by Medi-Tech Intl. Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2011-04-25.
- Submission: K110377
- Applicant / Sponsor: Medi-Tech Intl. Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6760
- Decision date: 2011-04-25
Classification & Regulation
This clearance is catalogued under FDA product code FMQ and 21 CFR 880.6760, within the General Hospital review panel as a Class I device.