FDA 510(k) Application Details - K133270

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K133270
Device Name	Staple, Fixation, Bone
Applicant	BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 SAN ANTONIO, TX 78245 US Other 510(k) Applications for this Company
Contact	JOE SOWARD Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2013
Decision Date	04/17/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review