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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 K052221
Device Name AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
Applicant
Sorenson Medical, Inc.
1375 W. 8040 S.
West Jordan,  UT  84088 -8320
Applicant Contact Douglas Bueschel
Correspondent
Sorenson Medical, Inc.
1375 W. 8040 S.
West Jordan,  UT  84088 -8320
Correspondent Contact Douglas Bueschel
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/15/2005
Decision Date 12/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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