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 | K203097 |
| 510k Number | K203097 |
| 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 | Rhonda M. Kops |
| Correspondent | Rhonda M. Kops 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 | 2020-10-14 |
| Decision Date | 2020-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911102479 | K203097 | 000 |
| 00841911103639 | K203097 | 000 |
| 10841911103643 | K203097 | 000 |
| 10841911103667 | K203097 | 000 |
| 10841911103674 | K203097 | 000 |
| 10841911102394 | K203097 | 000 |
| 10841911102424 | K203097 | 000 |
| 10841911102431 | K203097 | 000 |
| 10841911102448 | K203097 | 000 |
| 10841911102462 | K203097 | 000 |
| 00841911103530 | K203097 | 000 |