FDA 510(k) Application Details - K003629

Device Classification Name	Prosthesis, Toe, Hemi-, Phalangeal   More FDA Info for this Device
510(K) Number	K003629
Device Name	Prosthesis, Toe, Hemi-, Phalangeal
Applicant	TERRAY CORP. 49 JACKSON LANE PINE GROVE INDUSTRIAL PARK ARNPRIOR, ONTARIO K7S 3G8 CA Other 510(k) Applications for this Company
Contact	STEVE WANG 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	11/24/2000
Decision Date	02/22/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review