510(k) K100994
K100994 is an FDA 510(k) premarket notification submitted by Carbon Medical Technologies, Inc. for the device "PRELOADED TISSUE MARKER DEVICE". The FDA issued a decision of Substantially Equivalent on April 30, 2010. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Carbon Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2010
- Date Received
- April 9, 2010
- 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