FDA 510(k) Application Details - K043190

Device Classification Name Abutment, Implant, Dental, Endosseous

  More FDA Info for this Device
510(K) Number K043190
Device Name Abutment, Implant, Dental, Endosseous
Applicant INNOVA LIFE SCIENCES CORP.
555 13TH ST. N.W.
WASHINGTON, DC 20004 US
Other 510(k) Applications for this Company
Contact HOWARD HOLSTEIN
Other 510(k) Applications for this Contact
Regulation Number 872.3630

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

  More FDA Info for this Product Code
Date Received 11/17/2004
Decision Date 12/14/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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