510(k) K063750

XCEL 255 SLIT LAMP by Reichert, Inc. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2006
Date Received
December 19, 2006
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