510(k) K014148
K014148 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "SELF-DRILLING RADIOGRAPHIC MARKER". The FDA issued a decision of Substantially Equivalent on January 17, 2002. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2002
- Date Received
- December 18, 2001
- 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