FDA 510(k) Application Details - K231023

Device Classification Name	Lavage, Jet   More FDA Info for this Device
510(K) Number	K231023
Device Name	Lavage, Jet
Applicant	Erbe Elektromedizin GmbH Waldhoernlestrasse 17 Tuebingen 72072 DE Other 510(k) Applications for this Company
Contact	Matthias Kollek 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	04/11/2023
Decision Date	06/15/2023
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