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510(k) K941803

PRISM MEDICAL CUSTOM DIALYSIS KIT by Medical Device Support Services — Product Code KOC

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
January 30, 1995
Date Received
April 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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