POR — Parenteral Administration Kit Class II
FDA product code POR covers "Parenteral Administration Kit", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- POR
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.