Clearance Summary
SURETIP SYRINGE TIP COVER received FDA 510(k) clearance under submission number K931772, sponsored by Western M/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 1994-03-07.
- Submission: K931772
- Applicant / Sponsor: Western M/D, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1994-03-07
Classification & Regulation
This clearance is catalogued under FDA product code ECB and 21 CFR 872.4565, within the Dental review panel as a Class I device.