FDA 510(k) Application Details - K972411

Device Classification Name	Cement Obturator   More FDA Info for this Device
510(K) Number	K972411
Device Name	Cement Obturator
Applicant	TURNKEY INTERGRATION USA, INC. 321 PALMER RD. DENVILLE, NJ 07834 US Other 510(k) Applications for this Company
Contact	DOUGLAS W STUART 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	06/26/1997
Decision Date	08/29/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review