[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: 21CFR874.3730]

[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. 874.3730  Laryngeal prosthesis (Taub design).

    (a) Identification. A laryngeal prosthesis (Taub design) is a device 
intended to direct pulmonary air flow to the pharynx in the absence of 
the larynx, thereby permitting esophageal speech. The device is 
interposed between openings in the trachea and the esophagus and may be 
removed and replaced each day by the patient. During phonation, air from 
the lungs is directed to flow through the device and over the esophageal 
mucosa to provide a sound source that is articulated as speech.
    (b) Classification. Class II.

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