FDA 510(k) Application Details - K060920

Device Classification Name

  More FDA Info for this Device
510(K) Number K060920
Device Name VELSCOPE
Applicant LED MEDICAL DIAGNOSTICS INC.
#201-15047 MARINE DR.
WHITE ROCK, BRITISH COLUMBIA V4B 1C5 CA
Other 510(k) Applications for this Company
Contact DAVID C MORGAN
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 04/04/2006
Decision Date 04/27/2006
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