Clearance Summary
ORBITAL RECONSTRUCTIVE IMPLANT received FDA 510(k) clearance under submission number K070130, sponsored by Becker & Associates Consulting, 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 2007-04-19.
- Submission: K070130
- Applicant / Sponsor: Becker & Associates Consulting, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3320
- Decision date: 2007-04-19
Classification & Regulation
This clearance is catalogued under FDA product code HPZ and 21 CFR 886.3320, within the Ophthalmic review panel as a Class II device.