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For Class III devicesThe article is subject to refusal of admission pursuantto Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1). [Adulteration, Section 501(f)(1)(B)] OASIS charge code NO PMA For

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