510(k) K190689
K190689 is an FDA 510(k) premarket notification submitted by View Point Medical, Inc. for the device "SignalMark Breast Marker". The FDA issued a decision of Substantially Equivalent on August 14, 2019. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. View Point Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2019
- Date Received
- March 18, 2019
- 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