Clearance Summary
VAC-G (GUILLOTINE VITRECTOR) received FDA 510(k) clearance under submission number K881519, sponsored by B&B Medical Assoc., 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 1988-09-08.
- Submission: K881519
- Applicant / Sponsor: B&B Medical Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4150
- Decision date: 1988-09-08
Classification & Regulation
This clearance is catalogued under FDA product code HQE and 21 CFR 886.4150, within the Ophthalmic review panel as a Class II device.