MIXED MEDIA MARKER

Marker, Radiographic, Implantable

CORTEX MANUFACTURING, INC.

The following data is part of a premarket notification filed by Cortex Manufacturing, Inc. with the FDA for Mixed Media Marker.

Pre-market Notification Details

Device IDK102506
510k NumberK102506
Device Name:MIXED MEDIA MARKER
ClassificationMarker, Radiographic, Implantable
Applicant CORTEX MANUFACTURING, INC. 421 S. DAVIES RD. Lake Stevens,  WA  98258
ContactAndrew Jones
CorrespondentAndrew Jones
CORTEX MANUFACTURING, INC. 421 S. DAVIES RD. Lake Stevens,  WA  98258
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-01
Decision Date2011-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853730006336 K102506 000
00853730006107 K102506 000
00853730006114 K102506 000
00853730006121 K102506 000
00853730006176 K102506 000
00853730006183 K102506 000
00853730006190 K102506 000
00853730006206 K102506 000
00853730006213 K102506 000
00853730006220 K102506 000
00853730006237 K102506 000
00853730006244 K102506 000
00853730006251 K102506 000
00853730006268 K102506 000
00853730006091 K102506 000

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