FDA 510(k) Application Details - K972463

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K972463
Device Name	Plate, Bone
Applicant	BIOMEDICS 536 SOUTH RIMPAU BLVD. LOS ANGELES, CA 90020 US Other 510(k) Applications for this Company
Contact	CAROL E JONES Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	JEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/1997
Decision Date	09/25/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review