Concert Medical Hands-Free Syringe (HFS)

Pump, Infusion

Concert Medical, LLC

The following data is part of a premarket notification filed by Concert Medical, Llc with the FDA for Concert Medical Hands-free Syringe (hfs).

Pre-market Notification Details

Device IDK153599
510k NumberK153599
Device Name:Concert Medical Hands-Free Syringe (HFS)
ClassificationPump, Infusion
Applicant Concert Medical, LLC 77 Accord Park Drive Norwell,  MA  02061
ContactTimothy S Powers
CorrespondentPamela Papineau
Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer,  MA  01432
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-16
Decision Date2016-09-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850316008036 K153599 000
00850316008029 K153599 000
00850316008012 K153599 000
35060727270038 K153599 000
05060727270020 K153599 000
05060727270013 K153599 000
35060727270052 K153599 000
05060727270068 K153599 000

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