510(k) K800192

DURALITE LENS by American Optical Corp. — Product Code HPX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1980
Date Received
January 29, 1980
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