DS Small Extremity 16CH 1.5T Coil

Coil, Magnetic Resonance, Specialty

INVIVO THERAPEUTICS CORPORATION

The following data is part of a premarket notification filed by Invivo Therapeutics Corporation with the FDA for Ds Small Extremity 16ch 1.5t Coil.

Pre-market Notification Details

Device IDK162863
510k NumberK162863
Device Name:DS Small Extremity 16CH 1.5T Coil
ClassificationCoil, Magnetic Resonance, Specialty
Applicant INVIVO THERAPEUTICS CORPORATION 3545 SW 47th Ave Gainesville,  FL  32608
ContactKen Revennaugh
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2016-10-13
Decision Date2016-11-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838087408 K162863 000
00884838086401 K162863 000
00884838081666 K162863 000
00884838081659 K162863 000

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