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510(k) K022203

ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 by Abbott Laboratories — Product Code MEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2002
Date Received
July 5, 2002
Clearance Type
Special
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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