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510(k) K801440

SORB 10 DIALYSATE INFUSATE C1 INFUSATE by Organon Teknika Corp. — Product Code FKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1980
Date Received
June 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Sorbent Regenerated
Device Class
Class II
Regulation Number
876.5600
Review Panel
GU
Submission Type

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