FDA 510(k) Application Details - K041303

Device Classification Name Activator, Ultraviolet, For Polymerization

  More FDA Info for this Device
510(K) Number K041303
Device Name Activator, Ultraviolet, For Polymerization
Applicant APOZA ENTERPRISE CO. LTD.
6 F,NO.657, CHUANG CHENG ROAD
HSIN-CHUANG CITY
TAIPEI HSIEN 242 TW
Other 510(k) Applications for this Company
Contact SHIN MIN TEH
Other 510(k) Applications for this Contact
Regulation Number 872.6070

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

  More FDA Info for this Product Code
Date Received 05/17/2004
Decision Date 06/18/2004
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