510(k) K022413

LUNEAU 3 MIRROR LENS by Luneau SA — Product Code HJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2002
Date Received
July 24, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class
Class II
Regulation Number
886.1385
Review Panel
OP
Submission Type