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510(k) K913515

TOTAL CONTAINMENT DEVICE by Denco — Product Code KPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1994
Date Received
August 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Semi-Automatic, Peritoneal
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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