DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM

Pump, Infusion, Elastomeric

SYMBIOS MEDICAL PRODUCTS, LLC

The following data is part of a premarket notification filed by Symbios Medical Products, Llc with the FDA for Disposable Infusion Pump Kit, Go Pump Rapid Recovery System.

Pre-market Notification Details

Device IDK072921
510k NumberK072921
Device Name:DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
ClassificationPump, Infusion, Elastomeric
Applicant SYMBIOS MEDICAL PRODUCTS, LLC 7301 GEORGETOWN RD SUITE 150 Indianapolis,  IN  46268 -4194
ContactJeffrey Alholm
CorrespondentJeffrey Alholm
SYMBIOS MEDICAL PRODUCTS, LLC 7301 GEORGETOWN RD SUITE 150 Indianapolis,  IN  46268 -4194
Product CodeMEB  
Subsequent Product CodeBSO
Subsequent Product CodeKGZ
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-15
Decision Date2007-11-26

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