510(k) K925606

OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS by Chiron Vision Corp. — Product Code HMR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1994
Date Received
November 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Ocular
Device Class
Class I
Regulation Number
886.4570
Review Panel
OP
Submission Type