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510(k) K854084

PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT by Organon Teknika Corp. — Product Code FKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1985
Date Received
October 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insert, Pump, Blood
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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