510(k) K922253

KERATOREF L60 by Luneau Ophtalmologie SA — Product Code HLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1992
Date Received
May 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoscope, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
Review Panel
OP
Submission Type