Day

July 9, 2001
09
Jul

SciOptic International

July 9, 2001
Company: SciOptic InternationalDate: 7/9/01 SciOptic has contended that the _____ could be considered as a “custom device” within the meaning of 21 CFR 812.3(b). FDA has previously informed you that the _____ is not a custom device as it does not meet the necessary criteria found in section 520(b) of the Act, or in 21...
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