INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR

Marker, Radiographic, Implantable

MEDICAL DEVICE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Interv Brand V-mark Breast Biopsy Site Marker With Titanium Anchor.

Pre-market Notification Details

Device IDK053518
510k NumberK053518
Device Name:INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
ClassificationMarker, Radiographic, Implantable
Applicant MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVE. Gainesville,  FL  32608
ContactKristine Liberacki
CorrespondentKristine Liberacki
MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVE. Gainesville,  FL  32608
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-19
Decision Date2006-01-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20886333007183 K053518 000
00886333007172 K053518 000
20886333007169 K053518 000
20886333007152 K053518 000
20886333007145 K053518 000

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