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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, Elastomeric
510(k) Number K051474
Device Name SYMBIOS DISPOSABLE INFUSION PUMP KIT
Applicant
Symbios Medical Products, LLC
6131 W. 80th St.
Indianapolis,  IN  46278
Applicant Contact JEFFERY J ALHOLM
Correspondent
Symbios Medical Products, LLC
6131 W. 80th St.
Indianapolis,  IN  46278
Correspondent Contact JEFFERY J ALHOLM
Regulation Number880.5725
Classification Product Code
MEB  
Subsequent Product Codes
BSO   KGZ  
Date Received06/03/2005
Decision Date 07/01/2005
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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