510(k) K900295

PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES by Microwave Medical Systems, Inc. — Product Code KDJ

K900295 is an FDA 510(k) premarket notification submitted by Microwave Medical Systems, Inc. for the device "PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on November 21, 1990. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Microwave Medical Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1990
Date Received
January 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type