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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K852827
Device Name CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact BETTY HERNANDEZ
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact BETTY HERNANDEZ
Regulation Number882.5880
Classification Product Code
GZB  
Date Received07/02/1985
Decision Date 08/14/1985
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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