The following data is part of a premarket notification filed by Suros Surgical Systems, Inc. with the FDA for Tissue Site Marking System.
| Device ID | K062528 |
| 510k Number | K062528 |
| Device Name: | TISSUE SITE MARKING SYSTEM |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SUROS SURGICAL SYSTEMS, INC. 6100 TECHNOLOGY CENTER DR. Indianapolis, IN 46278 |
| Contact | Heidi Strunk |
| Correspondent | Heidi Strunk SUROS SURGICAL SYSTEMS, INC. 6100 TECHNOLOGY CENTER DR. Indianapolis, IN 46278 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-29 |
| Decision Date | 2007-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420045503963 | K062528 | 000 |
| 05420045503406 | K062528 | 000 |
| 05420045503598 | K062528 | 000 |
| 05420045503604 | K062528 | 000 |
| 05420045503611 | K062528 | 000 |
| 05420045503628 | K062528 | 000 |
| 05420045503918 | K062528 | 000 |
| 05420045503925 | K062528 | 000 |
| 05420045503932 | K062528 | 000 |
| 05420045503949 | K062528 | 000 |
| 05420045503956 | K062528 | 000 |
| 05420045503390 | K062528 | 000 |