FDA 510(k) Application Details - K082384

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K082384
Device Name	Washer, Bolt Nut
Applicant	INSTRATEK, INC. 210 SPRINGHILL DR. SUITE 130 SPRING, TX 77386 US Other 510(k) Applications for this Company
Contact	Jeff Seavey 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	08/19/2008
Decision Date	12/08/2008
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