PKF — D And C Tray Class N
FDA product code PKF covers "D And C Tray", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PKF
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Unknown
- 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.