Clearance Summary
KENDRICK EXTRICATION DEVICE received FDA 510(k) clearance under submission number K781761, sponsored by Medi-Ked, Inc.. 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 1978-10-27.
- Submission: K781761
- Applicant / Sponsor: Medi-Ked, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3490
- Decision date: 1978-10-27
Classification & Regulation
This clearance is catalogued under FDA product code IQF and 21 CFR 890.3490, within the Physical Medicine review panel as a Class I device.