Clearance Summary
UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS received FDA 510(k) clearance under submission number K942519, sponsored by Bull Frog Mfg. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-08-23.
- Submission: K942519
- Applicant / Sponsor: Bull Frog Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1994-08-23
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.