Part 878 Subpart B—Diagnostic Devices

FDA submissions for Part 878 Subpart B—Diagnostic Devices in the General, Plastic Surgery (SU) review panel, including product codes and regulations.

Section range: § 878.1800

CFR Part: 878

Product Codes

Product CodeDevice NameRegulationClassDevices
EPYSpeculum, Ent878.1800112
FXESpeculum, Non-Illuminated878.180010
FXFSpeculum, Illuminated878.180011
FXGSpecula Accessories878.180011
JYKHolder, Ear Speculum878.180011
KAGHolder, Speculum, Ent878.180012
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