510(k) K031753

KARATS MULTIPURPOSE SOLUTION by Ciba Vision Corporation — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2004
Date Received
June 5, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type