FDA 510(k) Application Details - K041820

Device Classification Name Case, Contact Lens

  More FDA Info for this Device
510(K) Number K041820
Device Name Case, Contact Lens
Applicant CIBA VISION CORPORATION
11460 JOHNS CREEK PARKWAY
DULUTH, GA 30097 US
Other 510(k) Applications for this Company
Contact STEVEN DOWDLEY
Other 510(k) Applications for this Contact
Regulation Number 886.5928

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

  More FDA Info for this Product Code
Date Received 07/06/2004
Decision Date 09/09/2005
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



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