Clearance Summary
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK received FDA 510(k) clearance under submission number K082132, sponsored by Bausch & Lomb, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2008-08-28.
- Submission: K082132
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 2008-08-28
Classification & Regulation
This clearance is catalogued under FDA product code HQC and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.