510(k) K042902
K042902 is an FDA 510(k) premarket notification submitted by Stuckenbrock Medizintechnik GmbH for the device "HERBERT ULNAR HEAD PROSTHESIS SYSTEM". The FDA issued a decision of Substantially Equivalent on December 27, 2004. The device falls under product code KXE (Prosthesis, Wrist, Hemi-, Ulnar), a Class II device regulated under 21 CFR 888.3810. Stuckenbrock Medizintechnik GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2004
- Date Received
- October 20, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, Hemi-, Ulnar
- Device Class
- Class II
- Regulation Number
- 888.3810
- Review Panel
- OR
- Submission Type