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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K882464
Device Name DTL MICROTOUCH EYE ELECTRODE
Applicant
Lectromedics, Inc.
1636 Ridgecrest
Rochester Hills,  MI  48064
Applicant Contact C SWORDS
Correspondent
Lectromedics, Inc.
1636 Ridgecrest
Rochester Hills,  MI  48064
Correspondent Contact C SWORDS
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/15/1988
Decision Date 11/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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