[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.4530]

[Page 381]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876_GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                       Subpart E_Surgical Devices
 
Sec. 876.4530  Gastroenterology-urology fiberoptic retractor.

    (a) Identification. A gastroenterology-urology fiberoptic retractor 
is a device that consists of a mechanical retractor with a fiberoptic 
light system that is used to illuminate deep surgical sites.
    (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 Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 
66 FR 38801, July 25, 2001]