[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: 21CFR874.3430]

[Page 367]
 
                        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. 874.3430  Middle ear mold.

    (a) Identification. A middle ear mold is a preformed device that is 
intended to be implanted to reconstruct the middle ear cavity during 
repair of the tympanic membrane. The device permits an ample air-filled 
cavity to be maintained in the middle ear and promotes regeneration of 
the mucous membrane lining of the middle ear cavity. A middle ear mold 
is made of materials such as polyamide, polytetrafluoroethylene, 
silicone elastomer, or polyethylene, but does not contain porous 
polyethylene.
    (b) Classification. Class II.

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