510(k) K895741

CLAS PHOTOKERATOSCOPE by Kera-Metrics Corp. — Product Code HLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1990
Date Received
September 26, 1989
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