Clearance Summary
SANI-SLEEVE DRAPE FOR DENTAL USE received FDA 510(k) clearance under submission number K885299, sponsored by Nieusma R & D, 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 1989-03-16.
- Submission: K885299
- Applicant / Sponsor: Nieusma R & D, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1989-03-16
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.