Beacon Tissue Marker (SE)

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 Beacon Tissue Marker (se).

Pre-market Notification Details

Device IDK153189
510k NumberK153189
Device Name:Beacon Tissue Marker (SE)
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 Received2015-11-03
Decision Date2015-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30866479000115 K153189 000

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