[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4660]

[Page 371]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 878--GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]