FDA 510(k) Application Details - K053333

Device Classification Name Plug, Punctum

  More FDA Info for this Device
510(K) Number K053333
Device Name Plug, Punctum
Applicant EAGLE VISION, INC.
8500 WOLF LAKE DR.
SUITE 110
MEMPHIS, TN 38133 US
Other 510(k) Applications for this Company
Contact JEFF COBB
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 12/01/2005
Decision Date 05/02/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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