Clearance Summary
CHIN-UP STRIP received FDA 510(k) clearance under submission number K040491, sponsored by Dale Miller, Inc. - the Chin-Up Company. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2004-09-10.
- Submission: K040491
- Applicant / Sponsor: Dale Miller, Inc. - the Chin-Up Company
- Clearance pathway: Abbreviated
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3900
- Decision date: 2004-09-10
Classification & Regulation
This clearance is catalogued under FDA product code LWF and 21 CFR 874.3900, within the Ear, Nose, Throat review panel as a Class I device.