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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 K852326
Device Name UNISTIM UNT-1
Applicant
NEUROMED, INC.
5000-A OAKES RD., SUITE A
FT. LAUDERDALE,  FL  33314
Applicant Contact WILLIAM F JACKSON
Correspondent
NEUROMED, INC.
5000-A OAKES RD., SUITE A
FT. LAUDERDALE,  FL  33314
Correspondent Contact WILLIAM F JACKSON
Regulation Number882.5880
Classification Product Code
GZB  
Date Received05/30/1985
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
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