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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 K050324
Device Name INFPUMP INFILTRATION PUMP
Applicant
Carolina Medical, Inc.
157 Industrial Dr.
King,  NC  27030
Applicant Contact LEON WILSON
Correspondent
Carolina Medical, Inc.
157 Industrial Dr.
King,  NC  27030
Correspondent Contact LEON WILSON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/09/2005
Decision Date 04/27/2005
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
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