Clearance Summary
AUTOMATIC TEFLON INJECTION SYRINGE received FDA 510(k) clearance under submission number K810284, sponsored by R. Wolf Medical Instruments Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1981-03-11.
- Submission: K810284
- Applicant / Sponsor: R. Wolf Medical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5220
- Decision date: 1981-03-11
Classification & Regulation
This clearance is catalogued under FDA product code KCP and 21 CFR 874.5220, within the Ear, Nose, Throat review panel as a Class I device.