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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 K072921
Device Name DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
Applicant
Symbios Medical Products, LLC
7301 Georgetown Rd.
Suite 150
Indianapolis,  IN  46268 -4194
Applicant Contact JEFFREY ALHOLM
Correspondent
Symbios Medical Products, LLC
7301 Georgetown Rd.
Suite 150
Indianapolis,  IN  46268 -4194
Correspondent Contact JEFFREY ALHOLM
Regulation Number880.5725
Classification Product Code
MEB  
Subsequent Product Codes
BSO   KGZ  
Date Received10/15/2007
Decision Date 11/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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