FDA 510(k) Application Details - K102641

Device Classification Name Plate, Bone

  More FDA Info for this Device
510(K) Number K102641
Device Name Plate, Bone
Applicant NEOORTHO PRODUTOS ORTOPEDICOS S/A
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO, CA 92130 US
Other 510(k) Applications for this Company
Contact LINDA K SCHULZ
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 09/13/2010
Decision Date 12/20/2010
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



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