CFR
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878.5650—Topical oxygen chamber for extremities.
(a) Identification.
A topical oxygen chamber for extremities is a device intended to surround hermetically a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers or bed sores.
(c) Date PMA or notice of completion of a PDP is required.
No effective date has been established of the requirement for premarket approval. See § 878.3.
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