FDA 510(k) Application Details - K000019

Device Classification Name	Prosthesis, Tendon, Passive   More FDA Info for this Device
510(K) Number	K000019
Device Name	Prosthesis, Tendon, Passive
Applicant	MEDIST INTERNATIONAL 9160 HIGHWAY 64 SUITE 12 LAKELAND, TN 38002 US Other 510(k) Applications for this Company
Contact	BERNARD F GRISONI Other 510(k) Applications for this Contact
Regulation Number	888.3025   More FDA Info for this Regulation Number
Classification Product Code	HXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2000
Decision Date	03/29/2000
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