TISSUE SITE MARKING SYSTEM

Marker, Radiographic, Implantable

SUROS SURGICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Suros Surgical Systems, Inc. with the FDA for Tissue Site Marking System.

Pre-market Notification Details

Device IDK062528
510k NumberK062528
Device Name:TISSUE SITE MARKING SYSTEM
ClassificationMarker, Radiographic, Implantable
Applicant SUROS SURGICAL SYSTEMS, INC. 6100 TECHNOLOGY CENTER DR. Indianapolis,  IN  46278
ContactHeidi Strunk
CorrespondentHeidi Strunk
SUROS SURGICAL SYSTEMS, INC. 6100 TECHNOLOGY CENTER DR. Indianapolis,  IN  46278
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-29
Decision Date2007-01-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05420045503963 K062528 000
05420045503406 K062528 000
05420045503598 K062528 000
05420045503604 K062528 000
05420045503611 K062528 000
05420045503628 K062528 000
05420045503918 K062528 000
05420045503925 K062528 000
05420045503932 K062528 000
05420045503949 K062528 000
05420045503956 K062528 000
05420045503390 K062528 000

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