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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 K915333
Device Name ELECTRODE USING PROMEON RG-60 SERIES GEL
Applicant
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Applicant Contact LORA L.JONES
Correspondent
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Correspondent Contact LORA L.JONES
Regulation Number882.1320
Classification Product Code
GXY  
Date Received11/26/1991
Decision Date 01/14/1992
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
Recalls CDRH Recalls
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