Clearance Summary
CYLINDER OF GAS, CAN OF GAS (CC12F2) received FDA 510(k) clearance under submission number K921617, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1992-08-05.
- Submission: K921617
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 1992-08-05
Classification & Regulation
This clearance is catalogued under FDA product code HKX and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.