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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 K853643
Device Name MULTISTIM LAMINECTOMY ELECTRODE
Applicant
Neuromed, Inc.
5000-A Oakes Rd., Suite A
Ft. Lauderdale,  FL  33314
Applicant Contact FRANK LISKA
Correspondent
Neuromed, Inc.
5000-A Oakes Rd., Suite A
Ft. Lauderdale,  FL  33314
Correspondent Contact FRANK LISKA
Regulation Number882.5880
Classification Product Code
GZB  
Date Received09/03/1985
Decision Date 11/14/1985
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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