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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 K071735
Device Name MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
Applicant
SYMBIOS MEDICAL PRODUCTS, LLC
7301 GEORGETOWN RD., SUITE 150
INDIANAPOLIS,  IN  46268
Applicant Contact MICHAEL JAMES
Correspondent
SYMBIOS MEDICAL PRODUCTS, LLC
7301 GEORGETOWN RD., SUITE 150
INDIANAPOLIS,  IN  46268
Correspondent Contact MICHAEL JAMES
Regulation Number880.5725
Classification Product Code
MEB  
Subsequent Product Codes
BSO   KGZ  
Date Received06/26/2007
Decision Date 07/19/2007
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
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