The following data is part of a premarket notification filed by Devicor Medical Products, Inc. with the FDA for Hydromark Breast Biopsy Site Marker.
| Device ID | K161021 |
| 510k Number | K161021 |
| Device Name: | HydroMARK Breast Biopsy Site Marker |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-12 |
| Decision Date | 2016-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911101519 | K161021 | 000 |
| 10841911101502 | K161021 | 000 |
| 10841911100147 | K161021 | 000 |
| 10841911100130 | K161021 | 000 |
| 10841911102318 | K161021 | 000 |
| 10841911102301 | K161021 | 000 |
| 10841911102196 | K161021 | 000 |
| 10841911102189 | K161021 | 000 |