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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K880426
Device Name ELECTROSTIMULATOR MODEL 808
Applicant
CORNELL ENTERPRISES CO., INC.
8361 VICKERS ST.
SUITE 208
SAN DIEGO,  CA  92111
Applicant Contact CORNELL N FUNG
Correspondent
CORNELL ENTERPRISES CO., INC.
8361 VICKERS ST.
SUITE 208
SAN DIEGO,  CA  92111
Correspondent Contact CORNELL N FUNG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/01/1988
Decision Date 09/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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