FDA 510(k) Application Details - K161165

Device Classification Name	Lavage, Jet   More FDA Info for this Device
510(K) Number	K161165
Device Name	Lavage, Jet
Applicant	NEXT SCIENCE, LLC 8130 BAYMEADOWS WAY WEST, SUITE 200 JACKSONVILLE, FL 33256 US Other 510(k) Applications for this Company
Contact	MATTHEW MYNTTI Other 510(k) Applications for this Contact
Regulation Number	880.5475   More FDA Info for this Regulation Number
Classification Product Code	FQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2016
Decision Date	09/07/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review