L K C TECHNOLOGIES, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrode, Cutaneous (GXY) (1)

Premarket Exempt

Clear

RETeval™ - 20857901006006 Catalog Number : Sensor Strips

Device Description : Bag of 25 pairs (1-right & 1-left per pair) of electrodes for use with the RETev Bag of 25 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electrophysiology system.

Device Class :

Duns Number: 606234730

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 25

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