FDA 510(k) Application Details - K050357

Device Classification Name Filler, Bone Void, Calcium Compound

  More FDA Info for this Device
510(K) Number K050357
Device Name Filler, Bone Void, Calcium Compound
Applicant CAM IMPLANTS B.V.
Zernikedreef 6
Leiden 2333 CL NL
Other 510(k) Applications for this Company
Contact KIM GROENEWEGAN VAN DER WEIJDEN
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 02/14/2005
Decision Date 04/21/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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