FDA 510(k) Application Details - K003848

Device Classification Name	Component, Traction, Invasive   More FDA Info for this Device
510(K) Number	K003848
Device Name	Component, Traction, Invasive
Applicant	HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH ALLENDALE, NJ 07401-1677 US Other 510(k) Applications for this Company
Contact	KAREN ARIEMMA 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	12/12/2000
Decision Date	01/11/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review