The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Inter V Brand V-mark Breast Biopsy Site Marker With Titanium Anchor.
| Device ID | K051421 |
| 510k Number | K051421 |
| Device Name: | INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR |
| Classification | Marker, Radiographic, Implantable |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Contact | Kristine Liberacki |
| Correspondent | Kristine Liberacki MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2005-08-30 |
| Summary: | summary |