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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K031185
Device Name ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
Applicant
ABBOTT LABORATORIES
D-389, BLDG. J45-2
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6157
Applicant Contact PATRICIA MELERSKI
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NEIL E DEVINE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/15/2003
Decision Date 04/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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