510(k) K111692
K111692 is an FDA 510(k) premarket notification submitted by Somatex Medical Technologies GmbH for the device "TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC". The FDA issued a decision of Substantially Equivalent on November 8, 2011. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Somatex Medical Technologies GmbH has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2011
- Date Received
- June 16, 2011
- 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