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 Identification System.
| Device ID | K072913 |
| 510k Number | K072913 |
| Device Name: | SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY 6100 TECHNOLOGY CENTER DR. Indianapolis, IN 46278 |
| Contact | Paula A Gray |
| Correspondent | Paula A Gray SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY 6100 TECHNOLOGY CENTER DR. Indianapolis, IN 46278 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-12 |
| Decision Date | 2008-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420045503482 | K072913 | 000 |
| 05420045503475 | K072913 | 000 |
| 05420045503468 | K072913 | 000 |
| 05420045503451 | K072913 | 000 |
| 05420045503444 | K072913 | 000 |
| 05420045503437 | K072913 | 000 |
| 05420045503420 | K072913 | 000 |
| 05420045503413 | K072913 | 000 |