510(k) K192371
K192371 is an FDA 510(k) premarket notification submitted by Focal Therapeutics for the device "BioZorb SP Marker". The FDA issued a decision of Substantially Equivalent on Sep 26, 2019. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Focal Therapeutics has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 26, 2019
- Date Received
- Aug 30, 2019
- Clearance Type
- Special
- 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
- 510(k)