Clearance Summary
SPAN-AID BRIDGING PILLOW SYSTEM received FDA 510(k) clearance under submission number K801518, sponsored by Span-America Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1980-08-04.
- Submission: K801518
- Applicant / Sponsor: Span-America Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 1980-08-04
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.