Clearance Summary
FIBER OPTIC ADAPTER #60-0897 received FDA 510(k) clearance under submission number K802768, sponsored by Aspen Laboratories, 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 1980-12-16.
- Submission: K802768
- Applicant / Sponsor: Aspen Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4350
- Decision date: 1980-12-16
Classification & Regulation
This clearance is catalogued under FDA product code EQH and 21 CFR 874.4350, within the Ear, Nose, Throat review panel as a Class I device.