FDA 510(k) Application Details - K111313

Device Classification Name	Lavage, Jet   More FDA Info for this Device
510(K) Number	K111313
Device Name	Lavage, Jet
Applicant	ALCAVIS HDC LLC 8322 Helgerman CT Gaithersburg, MD 20877 US Other 510(k) Applications for this Company
Contact	GARY J MISHKIN 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	05/10/2011
Decision Date	12/14/2011
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