Surgeons marker pen is a medical device, classified in Part 878 - GENERAL AND PLASTIC SURGERY DEVICES, Subpart E--Surgical Devices, Sec. 878.4660 Skin marker.
(a)Identification. A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
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