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 Marking System.
| Device ID | K102608 |
| 510k Number | K102608 |
| Device Name: | SECURMARK BIOPSY SITE MARKING SYSTEM |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY 6100 TECHNOLOGY CENTER DR. Indianapolis, IN 46278 |
| Contact | Alyssa M Lobo |
| Correspondent | Alyssa M Lobo 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 | 2010-09-10 |
| Decision Date | 2010-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420045503994 | K102608 | 000 |
| 05420045503826 | K102608 | 000 |
| 05420045503833 | K102608 | 000 |
| 05420045503840 | K102608 | 000 |
| 05420045503857 | K102608 | 000 |
| 05420045503864 | K102608 | 000 |
| 05420045503871 | K102608 | 000 |
| 05420045503970 | K102608 | 000 |
| 05420045503987 | K102608 | 000 |
| 05420045503819 | K102608 | 000 |