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510(k) K922757

SPS 1550 SINGLE NEEDLE PATIENT SYSTEM by Baxter Healthcare Corp — Product Code FKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1995
Date Received
June 9, 1992
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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