SECURMARK BIOPSY SITE MARKING SYSTEM

Marker, Radiographic, Implantable

SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY

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

Pre-market Notification Details

Device IDK102608
510k NumberK102608
Device Name:SECURMARK BIOPSY SITE MARKING SYSTEM
ClassificationMarker, Radiographic, Implantable
Applicant SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY 6100 TECHNOLOGY CENTER DR. Indianapolis,  IN  46278
ContactAlyssa M Lobo
CorrespondentAlyssa M Lobo
SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY 6100 TECHNOLOGY CENTER DR. Indianapolis,  IN  46278
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-10
Decision Date2010-10-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05420045503994 K102608 000
05420045503826 K102608 000
05420045503833 K102608 000
05420045503840 K102608 000
05420045503857 K102608 000
05420045503864 K102608 000
05420045503871 K102608 000
05420045503970 K102608 000
05420045503987 K102608 000
05420045503819 K102608 000

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