FDA 510(k) Application Details - K130953

Device Classification Name Filler, Bone Void, Calcium Compound

  More FDA Info for this Device
510(K) Number K130953
Device Name Filler, Bone Void, Calcium Compound
Applicant SBM SCIENCES FOR BIO MATERIALS
ZI DU MONGE
LOURDES 65100 FR
Other 510(k) Applications for this Company
Contact DENIS CLEMENT
Other 510(k) Applications for this Contact
Regulation Number 888.3045

  More FDA Info for this Regulation Number
Classification Product Code MQV
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 04/05/2013
Decision Date 07/15/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact