Clearance Summary
STOCKINGS, RVS TM received FDA 510(k) clearance under submission number K770466, sponsored by Parke-Davis Co.. 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 1977-03-28.
- Submission: K770466
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4750
- Decision date: 1977-03-28
Classification & Regulation
This clearance is catalogued under FDA product code EQL and 21 CFR 874.4750, within the Ear, Nose, Throat review panel as a Class I device.