FDA 510(k) Application Details - K180092

Device Classification Name	Wrench   More FDA Info for this Device
510(K) Number	K180092
Device Name	Wrench
Applicant	Gauthier Biomedical, Inc. 2221 Washington St. Grafton, WI 53024 US Other 510(k) Applications for this Company
Contact	Austin Braganza Other 510(k) Applications for this Contact
Regulation Number	888.4540   More FDA Info for this Regulation Number
Classification Product Code	HXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2018
Decision Date	03/08/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review