Clearance Summary
VIVONEX MASS GASTRASTOMY TUBE received FDA 510(k) clearance under submission number K822516, sponsored by Norwich Eaton Pharmaceuticals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1982-09-07.
- Submission: K822516
- Applicant / Sponsor: Norwich Eaton Pharmaceuticals, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5370
- Decision date: 1982-09-07
Classification & Regulation
This clearance is catalogued under FDA product code KHT and 21 CFR 866.5370, within the Immunology review panel as a Class I device.