Clearance Summary
SENNA received FDA 510(k) clearance under submission number K964744, sponsored by Trans-America Enterprises Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-01-29.
- Submission: K964744
- Applicant / Sponsor: Trans-America Enterprises Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1997-01-29
Classification & Regulation
This clearance is catalogued under FDA product code HQY and 21 CFR 886.5850, within the Ophthalmic review panel as a Class I device.