The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Secrmark Biopsy Site Marking System.
| Device ID | K102768 |
| 510k Number | K102768 |
| Device Name: | SECRMARK BIOPSY SITE MARKING SYSTEM |
| Classification | Marker, Radiographic, Implantable |
| Applicant | HOLOGIC, INC. 6100 TECHNOLOGY CENTER DRIVE Indianapolis, IN 46278 |
| Contact | Alyssa M Lobo |
| Correspondent | Alyssa M Lobo HOLOGIC, INC. 6100 TECHNOLOGY CENTER DRIVE 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 | 2010-09-24 |
| Decision Date | 2010-12-02 |
| Summary: | summary |