Clearance Summary
B & B I/A HANDPIECE received FDA 510(k) clearance under submission number K881517, 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 1988-08-22.
- Submission: K881517
- Applicant / Sponsor: B&B Medical Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4360
- Decision date: 1988-08-22
Classification & Regulation
This clearance is catalogued under FDA product code KYG and 21 CFR 886.4360, within the Ophthalmic review panel as a Class I device.