FDA 510(k) Application Details - K010840

Device Classification Name	Cement Obturator   More FDA Info for this Device
510(K) Number	K010840
Device Name	Cement Obturator
Applicant	ISOTIS NV 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA J M. NOLTE Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	LZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2001
Decision Date	04/20/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review