510(k) K940106

KERATOPLASTY SUTURING LENS by Visionary Technologies of Miami, Inc. — Product Code HPX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1994
Date Received
January 10, 1994
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