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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 K860158
Device Name 8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR
Applicant
Neuromed, Inc.
P.O. Box 290010
Davies,  FL  33329
Applicant Contact FRANK LISKA
Correspondent
Neuromed, Inc.
P.O. Box 290010
Davies,  FL  33329
Correspondent Contact FRANK LISKA
Regulation Number882.5880
Classification Product Code
GZB  
Date Received01/16/1986
Decision Date 03/07/1986
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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