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Class II Device

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Class II Device
A ‘medium risk’ medical device—e.g., hearing aids, syringes—approved by the FDA for use in humans

class II device
Regulatory affairs A 'medium risk' medical device–eg, hearing aids, syringes, approved by the FDA for use in humans. See 510(K.).


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Returning Class II devices is against FDA regulations, so make sure this is the one you want before you make a purchase.
Management agreed "that if the firm was selling the dental probes to distributors and end users that a 510(k) would be required since the dental probes are classified as accessories to a Class II device and have a Class II designation as well," the EIR stated.
Management agreed "that if the firm was selling the dental probes to distributors and end users that a 510(k) would be required since the dental probes are classified as accessories to a Class II device and have a Class II designation as well," the EIR stated.
 
 
 
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