510(k) K051940

CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA by Sis Ltd., Surgical Instrument Systems — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2005
Date Received
July 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type