PKF

D And C Tray

Product code

PKF

Device name

D And C Tray

Device class

Class N

Medical specialty

Unknown

Marketing pathway

Enforcement Discretion

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).