510(k) K203097
K203097 is an FDA 510(k) premarket notification submitted by Devicor Medical Products, Inc. for the device "HydroMARK Breast Biopsy Site Markers". The FDA issued a decision of Substantially Equivalent on December 16, 2020. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Devicor Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2020
- Date Received
- October 14, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Radiographic, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type