External prosthesis adhesive.

21 C.F.R. § 878.3750
in effectEffective: 2024-07-01
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(a) Identification. An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

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