FDA 510(k) Application Details - K113312

Device Classification Name	Lavage, Jet   More FDA Info for this Device
510(K) Number	K113312
Device Name	Lavage, Jet
Applicant	PATRIN PHARMA 7817 BABB AVE. SKOKIE, IL 60077 US Other 510(k) Applications for this Company
Contact	JAY S TRIVEDI 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	11/09/2011
Decision Date	08/21/2012
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