Clearance Summary
BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE received FDA 510(k) clearance under submission number K970930, sponsored by Cleft Palate Appliances, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-04-23.
- Submission: K970930
- Applicant / Sponsor: Cleft Palate Appliances, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1997-04-23
Classification & Regulation
This clearance is catalogued under FDA product code DYJ and 21 CFR 872.5410, within the Dental review panel as a Class I device.