Star Tissue Marker

Marker, Radiographic, Implantable

Scion Medical Technologies, LLC

The following data is part of a premarket notification filed by Scion Medical Technologies, Llc with the FDA for Star Tissue Marker.

Pre-market Notification Details

Device IDK170905
510k NumberK170905
Device Name:Star Tissue Marker
ClassificationMarker, Radiographic, Implantable
Applicant Scion Medical Technologies, LLC 4613 West Chester Pike Newtown Square,  PA  19073
ContactLouis Li
CorrespondentLouis Li
Scion Medical Technologies, LLC 4613 West Chester Pike Newtown Square,  PA  19073
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-28
Decision Date2017-04-27
Summary:summary

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