510(k) K895792

DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6 by National Medical Care, Medical Products Div., Inc. — Product Code KDJ

K895792 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6". The FDA issued a decision of Substantially Equivalent on March 23, 1990. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1990
Date Received
September 28, 1989
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