FDA 510(k) Application Details - K971117

Device Classification Name	Warmer, Irrigation Solution   More FDA Info for this Device
510(K) Number	K971117
Device Name	Warmer, Irrigation Solution
Applicant	OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH SEATTLE, WA 98108 US Other 510(k) Applications for this Company
Contact	JOSEPH P STEFANILE 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	03/27/1997
Decision Date	08/22/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review