FDA 510(k) Application Details - K021288

Device Classification Name	Warmer, Irrigation Solution   More FDA Info for this Device
510(K) Number	K021288
Device Name	Warmer, Irrigation Solution
Applicant	O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR. SUITE W CHANTILLY, VA 20151-1689 US Other 510(k) Applications for this Company
Contact	STEVE HANNES 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	04/23/2002
Decision Date	06/27/2002
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