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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 K901499
Device Name NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.
Applicant
NEUROMED, INC.
5000-A OAKES RD., SUITE A
FT. LAUDERDALE,  FL  33314
Applicant Contact CIPORKIN, MS
Correspondent
NEUROMED, INC.
5000-A OAKES RD., SUITE A
FT. LAUDERDALE,  FL  33314
Correspondent Contact CIPORKIN, MS
Regulation Number882.5880
Classification Product Code
GZB  
Date Received03/29/1990
Decision Date 06/29/1990
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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