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510(k) K894838

HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB by Baxter Healthcare Corp — Product Code FKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1989
Date Received
July 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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