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510(k) K031566

SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 by Baxter Healthcare Corp — Product Code MEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2003
Date Received
May 19, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Pca
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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