[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: 21CFR874.3540]

[Page 368]
 
                        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 D_Prosthetic Devices
 
Sec. 874.3540  Prosthesis modification instrument for ossicular
replacement surgery.

    (a) Identification. A prosthesis modification instrument for 
ossicular replacement surgery is a device intended for use by a surgeon 
to construct ossicular replacements. This generic type of device 
includes the ear, nose, and throat cutting block; wire crimper, wire 
bending die; wire closure forceps; piston cutting jib; gelfoam 
TM punch; wire cutting scissors; and ossicular finger vise.
    (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. 874.9. If the device is not labeled or 
otherwise represented as sterile, it is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with the 
exception of Sec. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.

[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 
FR 2316, Jan. 14, 2000]