FDA 510(k) Application Details - K955751

Device Classification Name	Cement Obturator   More FDA Info for this Device
510(K) Number	K955751
Device Name	Cement Obturator
Applicant	ORTHOPAEDIC INNOVATIONS, INC. 825 SOUTH 8TH ST. SUITE 700 MINNEAPOLIS, MN 55404 US Other 510(k) Applications for this Company
Contact	CAROLYN M STEELE 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	12/20/1995
Decision Date	01/26/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review