The following data is part of a premarket notification filed by Devicor Medical Products, Inc. with the FDA for Hydromark Breast Biopsy Site Markers.
| Device ID | K170803 |
| 510k Number | K170803 |
| Device Name: | HydroMARK Breast Biopsy Site Markers |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 |
| Contact | Shawna Rose |
| Correspondent | Shawna Rose Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-17 |
| Decision Date | 2017-06-15 |
| Summary: | summary |