Clearance Summary
GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR received FDA 510(k) clearance under submission number K952569, sponsored by Gamp & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1996-01-05.
- Submission: K952569
- Applicant / Sponsor: Gamp & Assoc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4100
- Decision date: 1996-01-05
Classification & Regulation
This clearance is catalogued under FDA product code HQR and 21 CFR 886.4100, within the Ophthalmic review panel as a Class II device.