FDA 510(k) Application Details - K192873

Device Classification Name	Orthopedic Manual Surgical Instrument   More FDA Info for this Device
510(K) Number	K192873
Device Name	Orthopedic Manual Surgical Instrument
Applicant	Sonex Health, Inc. 11 1st Ave SW Rochester, MN 55902 US Other 510(k) Applications for this Company
Contact	Aaron Keenan Other 510(k) Applications for this Contact
Regulation Number	888.4540   More FDA Info for this Regulation Number
Classification Product Code	LXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2019
Decision Date	12/20/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review