FDA 510(k) Application Details - K033930

Device Classification Name	Prosthesis, Wrist, Hemi-, Ulnar   More FDA Info for this Device
510(K) Number	K033930
Device Name	Prosthesis, Wrist, Hemi-, Ulnar
Applicant	KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD. CLEVELAND, OH 44128 US Other 510(k) Applications for this Company
Contact	ALBERT SANTILLI 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	12/18/2003
Decision Date	07/28/2004
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