FDA 510(k) Application Details - K210987

Device Classification Name	Lavage, Jet   More FDA Info for this Device
510(K) Number	K210987
Device Name	Lavage, Jet
Applicant	Inopro Inc 800 rue Sud Porte A Cowansville J2K 2Y3 CA Other 510(k) Applications for this Company
Contact	Alain Lefebvre 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	04/01/2021
Decision Date	05/31/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review