Clearance Summary
NUTIP (TM) SYRINGE SHIELD received FDA 510(k) clearance under submission number K911214, 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 1991-07-17.
- Submission: K911214
- Applicant / Sponsor: Western M/D, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1991-07-17
Classification & Regulation
This clearance is catalogued under FDA product code EKJ and 21 CFR 872.4565, within the Dental review panel as a Class I device.