FDA 510(k) Application Details - K964825

Device Classification Name	Warmer, Peritoneal Dialysate   More FDA Info for this Device
510(K) Number	K964825
Device Name	Warmer, Peritoneal Dialysate
Applicant	IMPACT CASE TECHNOLOGIES, INC. 20 STEELCASE RD., WEST, UNITS 6 & 7 MARKHAM, ONTARIO L3R 1B2 CA Other 510(k) Applications for this Company
Contact	ANGELA HAMLEN Other 510(k) Applications for this Contact
Regulation Number	876.5630   More FDA Info for this Regulation Number
Classification Product Code	MLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/1996
Decision Date	05/19/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review