510(k) K902451

LONG-LIFE Y-SET CAT. NO. 48-6366-8 by National Medical Care, Medical Products Div., Inc. — Product Code KDJ

K902451 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "LONG-LIFE Y-SET CAT. NO. 48-6366-8". The FDA issued a decision of Substantially Equivalent on August 14, 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
August 14, 1990
Date Received
June 1, 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