510(k) K100500

PSL CLASSIC SLIT LAMP by Keeler Instruments, Inc. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2010
Date Received
February 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type