FDA 510(k) Application Details - K993903

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K993903
Device Name	Cerclage, Fixation
Applicant	WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. ST. LOUIS, MO 63141 US Other 510(k) Applications for this Company
Contact	DEBRA MEYER Other 510(k) Applications for this Contact
Regulation Number	888.3010   More FDA Info for this Regulation Number
Classification Product Code	JDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/1999
Decision Date	02/14/2000
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