510(k) K930843

RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 by National Medical Care, Medical Products Div., Inc. — Product Code KDJ

K930843 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "RAPID DISCONNECT Y-SET, CAT. NO. 48-7000". The FDA issued a decision of Substantially Equivalent on August 31, 1994. 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 31, 1994
Date Received
February 18, 1993
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