FDA 510(k) Application Details - K983685

Device Classification Name	Fixation Accessory   More FDA Info for this Device
510(K) Number	K983685
Device Name	Fixation Accessory
Applicant	CHAPEL AND ASSOC. 1019 RIDGECREST CIRCLE DENTON, TX 76205 US Other 510(k) Applications for this Company
Contact	JAMES F CHAPEL Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	LYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/1998
Decision Date	12/04/1998
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