Clearance Summary
SYRINGE, EAR & ULCER received FDA 510(k) clearance under submission number K780599, sponsored by Abco Dealers, Inc.. 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 1978-04-19.
- Submission: K780599
- Applicant / Sponsor: Abco Dealers, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5220
- Decision date: 1978-04-19
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.