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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 K020881
Device Name MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
Applicant
Science Incorporated
12150 Nicollet Ave. S.
Burnsville,  MN  55337 -1647
Applicant Contact LYNN WEIST
Correspondent
Science Incorporated
12150 Nicollet Ave. S.
Burnsville,  MN  55337 -1647
Correspondent Contact LYNN WEIST
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/18/2002
Decision Date 03/27/2002
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
Predetermined Change
Control Plan Authorized		 No
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