FDA 510(k) Application Details - K133858

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K133858
Device Name	Washer, Bolt Nut
Applicant	DALLEN MEDICAL, INC. 1046 Calle Recodo Ste G San Clemente, CA 92673 US Other 510(k) Applications for this Company
Contact	AL MEMMOLO 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	12/19/2013
Decision Date	02/28/2014
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