FDA 510(k) Application Details - K984219

Device Classification Name Lens,Prescription,Color Deficiency

  More FDA Info for this Device
510(K) Number K984219
Device Name Lens,Prescription,Color Deficiency
Applicant COLOR VISION TECHNOLOGIES, INC.
19726 COLIMA RD.
SUITE 320
ROWLAND HEIGHTS, CA 91748 US
Other 510(k) Applications for this Company
Contact JULIE KIM
Other 510(k) Applications for this Contact
Regulation Number 886.5844

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

  More FDA Info for this Product Code
Date Received 11/25/1998
Decision Date 11/18/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K984219


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