FDA 510(k) Application Details - K213616

Device Classification Name	Lavage, Jet   More FDA Info for this Device
510(K) Number	K213616
Device Name	Lavage, Jet
Applicant	Becton, Dickinson and Company 75 N Fairway Dr Vernon Hills, IL 60061 US Other 510(k) Applications for this Company
Contact	Shelley Wilcox 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	11/15/2021
Decision Date	03/23/2022
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