Clearance Summary
IN6 SAFETY SYRINGE, MODEL 3ML received FDA 510(k) clearance under submission number K051800, sponsored by In6 Incuvestor, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2005-10-21.
- Submission: K051800
- Applicant / Sponsor: In6 Incuvestor, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2005-10-21
Classification & Regulation
This clearance is catalogued under FDA product code MEG and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.