510(k) K151998
K151998 is an FDA 510(k) premarket notification submitted by Augmenix, Inc. for the device "TraceIT Tissue Marker - 3mL". The FDA issued a decision of Substantially Equivalent on August 19, 2015. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Augmenix, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2015
- Date Received
- July 20, 2015
- 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