510(k) K053518

INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR by Medical Device Technologies, Inc. — Product Code NEU

K053518 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR". The FDA issued a decision of Substantially Equivalent on January 26, 2006. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.