FDA 510(k) Application Details - K970536

Device Classification Name	Protector, Transducer, Dialysis   More FDA Info for this Device
510(K) Number	K970536
Device Name	Protector, Transducer, Dialysis
Applicant	MEDISYSTEMS CORP. 1201 3RD AVE. SUITE 3900 SEATTLE, WA 98101-3016 US Other 510(k) Applications for this Company
Contact	FRED G SWINDLER Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/1997
Decision Date	05/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review