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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 K080743
Device Name LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP
Applicant
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ARDEN HILLS,  MN  55112
Applicant Contact DAVID H SHORT
Correspondent
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ARDEN HILLS,  MN  55112
Correspondent Contact DAVID H SHORT
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/17/2008
Decision Date 04/25/2008
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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