510(k) K013204

AQUIFY LENS COMFORT DROPS by Ciba Vision Corporation — Product Code MRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2002
Date Received
September 25, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Device Class
Class II
Regulation Number
886.5918
Review Panel
OP
Submission Type