FDA 510(k) Application Details - K983265

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K983265
Device Name	Washer, Bolt Nut
Applicant	DEPUY ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. EL SEGUNDO, CA 90245 US Other 510(k) Applications for this Company
Contact	KATHLEEN DRAGOVICH Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/1998
Decision Date	10/26/1998
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