510(k) K072219
K072219 is an FDA 510(k) premarket notification submitted by Cytophil, Inc. for the device "CYTOPHIL TISSUE MARKER". The FDA issued a decision of Substantially Equivalent on January 18, 2008. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Cytophil, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2008
- Date Received
- August 10, 2007
- 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