FDA 510(k) Application Details - K090848

Device Classification Name	Lavage, Jet   More FDA Info for this Device
510(K) Number	K090848
Device Name	Lavage, Jet
Applicant	PREMIER BRANDS OF AMERICA, INC. 120 PEARL ST. MOUNT VERNON, NY 10550 US Other 510(k) Applications for this Company
Contact	MACK CAUTHEN 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	03/30/2009
Decision Date	06/17/2009
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