Clearance Summary
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER received FDA 510(k) clearance under submission number K001368, sponsored by Carmel Pharma Ab.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2000-05-12.
- Submission: K001368
- Applicant / Sponsor: Carmel Pharma Ab.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2000-05-12
Classification & Regulation
This clearance is catalogued under FDA product code LHI and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.