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 |