Clearance Summary
DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 received FDA 510(k) clearance under submission number K892881, 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 1989-06-23.
- Submission: K892881
- Applicant / Sponsor: Nieusma R & D, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1989-06-23
Classification & Regulation
This clearance is catalogued under FDA product code EHZ and 21 CFR 872.6640, within the Dental review panel as a Class I device.