Clearance Summary
TURBOTRON 20/20 received FDA 510(k) clearance under submission number K902920, sponsored by Prestige Manufacturing Snd Bhd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1991-10-10.
- Submission: K902920
- Applicant / Sponsor: Prestige Manufacturing Snd Bhd
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 1991-10-10
Classification & Regulation
This clearance is catalogued under FDA product code LYL and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.