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51 FR 40389, Nov. 6, 1986, unless otherwise noted.
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Subscribe to: 21 CFR 874.3820
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Nomenclature changes to part 874 appear at 73 FR 35341, June 23, 2008.
(a) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to relieve the symptons of vertigo. The device permits the unrestricted flow of excess endolymph from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. This device is made of polytetrafluoroethylene or silicone elastomer.
(b) Classification. Class II.