Clearance Summary
IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS received FDA 510(k) clearance under submission number K112702, sponsored by Imperial Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-03-29.
- Submission: K112702
- Applicant / Sponsor: Imperial Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2012-03-29
Classification & Regulation
This clearance is catalogued under FDA product code LGZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.