FDA 510(k) Application Details - K022065

Device Classification Name	Component, Traction, Invasive   More FDA Info for this Device
510(K) Number	K022065
Device Name	Component, Traction, Invasive
Applicant	SINTEA BIOTECH, INC. 407 LINCOLN RD. SUITE 10L MIAMI BEACH, FL 33139 US Other 510(k) Applications for this Company
Contact	MARIANNE GRUNWALDT Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2002
Decision Date	08/06/2002
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