FDA 510(k) Application Details - K014164

Device Classification Name	Prosthesis, Toe, Hemi-, Phalangeal   More FDA Info for this Device
510(K) Number	K014164
Device Name	Prosthesis, Toe, Hemi-, Phalangeal
Applicant	HARMOS ORTHOPAEDICS, INC. 1002 FREDERICK RD. CATONSVILLE, MD 21228 US Other 510(k) Applications for this Company
Contact	RICHARD W WOODS Other 510(k) Applications for this Contact
Regulation Number	888.3730   More FDA Info for this Regulation Number
Classification Product Code	KWD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2001
Decision Date	03/12/2002
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