FDA 510(k) Application Details - K112111

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K112111
Device Name	Washer, Bolt Nut
Applicant	ACUMED LLC 5885 NW CORNELIUS PASS RD. HILLSBORO, OR 97124-9432 US Other 510(k) Applications for this Company
Contact	LINO TSAI 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	07/25/2011
Decision Date	11/14/2011
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