FDA 510(k) Application Details - K042902

Device Classification Name	Prosthesis, Wrist, Hemi-, Ulnar   More FDA Info for this Device
510(K) Number	K042902
Device Name	Prosthesis, Wrist, Hemi-, Ulnar
Applicant	STUCKENBROCK MEDIZINTECHNIK GMBH 12244 SW 130 ST. MIAMI, FL 33186 US Other 510(k) Applications for this Company
Contact	AL WEISENBORN Other 510(k) Applications for this Contact
Regulation Number	888.3810   More FDA Info for this Regulation Number
Classification Product Code	KXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2004
Decision Date	12/27/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review