FDA 510(k) Application Details - K170606

Device Classification Name	More FDA Info for this Device
510(K) Number	K170606
Device Name	Acrylic Herbst Appliance with Micro-Recorder
Applicant	Gergen's Orthodontic Lab 1745 West Deer Valley Rd, Suite 112 Phoenix, AZ 85027 US Other 510(k) Applications for this Company
Contact	Chris Morrison Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2017
Decision Date	11/16/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review