Clearance Summary
SYN-O-SCOPE NASAL INHALER received FDA 510(k) clearance under submission number K760674, sponsored by Mcdonald and Assoc., 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 1977-03-10.
- Submission: K760674
- Applicant / Sponsor: Mcdonald and Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5220
- Decision date: 1977-03-10
Classification & Regulation
This clearance is catalogued under FDA product code KCO and 21 CFR 874.5220, within the Ear, Nose, Throat review panel as a Class I device.