FDA 510(k) Application Details - K965136

Device Classification Name	Warmer, Irrigation Solution   More FDA Info for this Device
510(K) Number	K965136
Device Name	Warmer, Irrigation Solution
Applicant	PRINCETON REGULATORY ASSOC. 116 VILLAGE BLVD., SUITE 200 PRINCETON, NJ 08540-5799 US Other 510(k) Applications for this Company
Contact	THOMAS BECZE Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LHC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/1996
Decision Date	10/16/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review