Clearance Summary
PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE received FDA 510(k) clearance under submission number K923285, sponsored by Smith & Nephew, 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 1992-09-15.
- Submission: K923285
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1992-09-15
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.