CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA

Device, Analysis, Anterior Segment

SIS LTD. SURGICAL INSTRUMENT SYSTEMS

The following data is part of a premarket notification filed by Sis Ltd. Surgical Instrument Systems with the FDA for Cm 3910 Rotating Double Scheimpflug Camera.

Pre-market Notification Details

Device IDK051940
510k NumberK051940
Device Name:CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
ClassificationDevice, Analysis, Anterior Segment
Applicant SIS LTD. SURGICAL INSTRUMENT SYSTEMS 13 RED FOX LANE Littleton,  CO  80127
ContactKevin Walls
CorrespondentKevin Walls
SIS LTD. SURGICAL INSTRUMENT SYSTEMS 13 RED FOX LANE Littleton,  CO  80127
Product CodeMXK  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-18
Decision Date2005-09-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07640167751235 K051940 000

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