510(k) K001428

OPTIMUM WETTING AND REWETTING DROP by Lobob Laboratories, Inc. — Product Code MRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2000
Date Received
May 5, 2000
Clearance Type
Special
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