Summary of Safety and Clinical Performance

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Manufactured by:
Gentuity, LLC
142 North Road, Suite G
Sudbury, MA 01776-1142

USA Distributor:
Gentuity, LLC
142 North Road, Suite G
Sudbury, MA 01752

EMEA Distributor:
Nipro Medical Europe
Nipro European HQ
Blokhuisstraat 42
2800 Mechelen
Belgium