K-number	K170606
Device name	Acrylic Herbst Appliance with Micro-Recorder
Applicant	Gergen'S Orthodontic Lab
Product code	PLC
Device class	Class II
Decision date	Nov 16, 2017
Decision	Substantially Equivalent
Regulation	872.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Acrylic Herbst Appliance with Micro-Recorder

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