[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: 21CFR878.4100]

[Page 368]
 
                        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. 878.4100  Organ bag.

    (a) Identification. An organ bag is a device that is a flexible 
plastic bag intended to be used as a temporary receptacle for an organ 
during surgical procedures to prevent moisture loss.
    (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 Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 65 
FR 2318, Jan. 14, 2000]