510(k) K850909

RHODA-LUX LENS BLANKS by Optatint, Inc. — Product Code HPX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1985
Date Received
March 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Polymethylmethacrylate)
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type