FDA 510(k) Application Details - K011612

Device Classification Name	Lavage, Jet   More FDA Info for this Device
510(K) Number	K011612
Device Name	Lavage, Jet
Applicant	HYDROCISION, INC. 7 TIFFANY TRAIL HOPKINTON, MA 01748 US Other 510(k) Applications for this Company
Contact	DEBBIE IAMPIETRO 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	05/25/2001
Decision Date	06/22/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review