Clearance Summary
CRYSTAL EAR received FDA 510(k) clearance under submission number K942189, sponsored by Crystal Care Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1994-08-09.
- Submission: K942189
- Applicant / Sponsor: Crystal Care Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1994-08-09
Classification & Regulation
This clearance is catalogued under FDA product code ESD and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.