FDA 510(k) Application Details - K040497

Device Classification Name	Prosthesis, Wrist, Hemi-, Ulnar   More FDA Info for this Device
510(K) Number	K040497
Device Name	Prosthesis, Wrist, Hemi-, Ulnar
Applicant	APTIS MEDICAL, LLC. P.O. BOX 249 DEL MAR, CA 92014 US Other 510(k) Applications for this Company
Contact	LOUISE M FOCHT 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	02/26/2004
Decision Date	01/26/2005
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