[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: 21CFR878.4450]

[Page 369]
 
                        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. 878.4450  Nonabsorbable gauze for internal use.

    (a) Identification. Nonabsorbable gauze for internal use is a device 
made of an open mesh fabric intended to be used inside the body or a 
surgical incision or applied to internal organs or structures, to 
control bleeding, absorb fluid, or protect organs or structures from 
abrasion, drying, or contamination. The device is woven from material 
made of not less than 50 percent by mass cotton, cellulose, or a simple 
chemical derivative of cellulose, and contains x-ray detectable 
elements.
    (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 61 FR 1123, Jan. 16, 1996]