[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: 21CFR874.4800]

[Page 343]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                       Subpart E--Surgical Devices
 
Sec. 874.4800  Bone particle collector.

    (a) Identification. A bone particle collector is a filtering device 
intended to be inserted into a suction tube during the early stages of 
otologic surgery to collect bone particles for future use.
    (b) Classification. Class I (general controls). The device is exempt 
from premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 874.9.

[64 FR 10949, Mar. 8, 1999]