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.
Device ID | K053518 |
510k Number | K053518 |
Device Name: | INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR |
Classification | Marker, Radiographic, Implantable |
Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVE. Gainesville, FL 32608 |
Contact | Kristine Liberacki |
Correspondent | Kristine Liberacki MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVE. Gainesville, FL 32608 |
Product Code | NEU |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-19 |
Decision Date | 2006-01-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20886333007183 | K053518 | 000 |
00886333007172 | K053518 | 000 |
20886333007169 | K053518 | 000 |
20886333007152 | K053518 | 000 |
20886333007145 | K053518 | 000 |