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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 K033425
Device Name AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
Applicant
SORENSON MEDICAL, INC.
1375 WEST 8040 SOUTH
WEST JORDAN,  UT  84088 -8320
Applicant Contact Douglas Bueschel
Correspondent
SORENSON MEDICAL, INC.
1375 WEST 8040 SOUTH
WEST JORDAN,  UT  84088 -8320
Correspondent Contact Douglas Bueschel
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/27/2003
Decision Date 11/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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