Clearance Summary
MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE received FDA 510(k) clearance under submission number K812305, sponsored by Boston Medical Products, 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 1981-09-08.
- Submission: K812305
- Applicant / Sponsor: Boston Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1981-09-08
Classification & Regulation
This clearance is catalogued under FDA product code KCF and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.