FDA 510(k) Application Details - K982354

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K982354
Device Name	Washer, Bolt Nut
Applicant	SPECIAL DEVICES, INC. 12493 OLD ROUGH AND READY HWY. GRASS VALLEY, CA 95945 US Other 510(k) Applications for this Company
Contact	JOSEPH J SPRANZA 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	07/06/1998
Decision Date	11/23/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review