FDA 510(k) Application Details - K974387

Device Classification Name	Set, Administration, For Peritoneal Dialysis, Disposable   More FDA Info for this Device
510(K) Number	K974387
Device Name	Set, Administration, For Peritoneal Dialysis, Disposable
Applicant	MICROWAVE MEDICAL SYSTEMS, INC. 310-312 SCHOOL ST. ACTON, MA 01720 US Other 510(k) Applications for this Company
Contact	RICHARD S GRABOWY Other 510(k) Applications for this Contact
Regulation Number	876.5630   More FDA Info for this Regulation Number
Classification Product Code	KDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/1997
Decision Date	09/01/1999
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