510(k) K812771

PERITONEAL DIALYSIS DRAINAGE by Dravon Medical, Inc. — Product Code KDJ

K812771 is an FDA 510(k) premarket notification submitted by Dravon Medical, Inc. for the device "PERITONEAL DIALYSIS DRAINAGE". The FDA issued a decision of Substantially Equivalent on October 19, 1981. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Dravon Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1981
Date Received
October 5, 1981
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