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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, Pca
510(k) Number K162165
Device Name ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
Applicant
Summit Medical Products, Inc.
504 W. 8360 S.
Sandy,  UT  84070
Applicant Contact LeVoy Haight
Correspondent
Summit Medical Products, Inc.
504 W. 8360 S.
Sandy,  UT  84070
Correspondent Contact LeVoy Haight
Regulation Number880.5725
Classification Product Code
MEA  
Subsequent Product Code
FRN  
Date Received08/03/2016
Decision Date 08/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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