Clearance Summary
SOLA COMMIDO LOUPE received FDA 510(k) clearance under submission number K760770, sponsored by Codman & Shurtleff, 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 1976-10-15.
- Submission: K760770
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 1976-10-15
Classification & Regulation
This clearance is catalogued under FDA product code HLJ and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.