§ 878.4683. Non-Powered suction apparatus device intended for negative pressure wound therapy.
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/us/cfr/t21/s§ 878.4683·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.
(b)Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document. [75 FR 70114, Nov. 17, 2010]
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§ 878.4683
Non-Powered suction apparatus device intended for negative pressure wound therapy.
Fed. Reg.×1
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