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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 K111386
Device Name MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
Applicant
Smiths Medical MD, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact JAMES CHAPMAN
Correspondent
Smiths Medical MD, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact JAMES CHAPMAN
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
MRZ  
Date Received05/18/2011
Decision Date 08/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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