Clearance Summary
-OM WEST 2000 GNATUS CHAIR received FDA 510(k) clearance under submission number K863008, sponsored by Sds Dental, 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 1986-09-24.
- Submission: K863008
- Applicant / Sponsor: Sds Dental, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1140
- Decision date: 1986-09-24
Classification & Regulation
This clearance is catalogued under FDA product code HME and 21 CFR 886.1140, within the Ophthalmic review panel as a Class I device.