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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 K905569
Device Name ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
Applicant
BIOMEDICAL LIFE SYSTEMS, INC.
1285 STONE DR. #103
P.O. BOX 128
SAN MARCOS,  CA  92069
Applicant Contact RICHARD SAXON
Correspondent
BIOMEDICAL LIFE SYSTEMS, INC.
1285 STONE DR. #103
P.O. BOX 128
SAN MARCOS,  CA  92069
Correspondent Contact RICHARD SAXON
Regulation Number882.5880
Classification Product Code
GZB  
Date Received12/12/1990
Decision Date 06/27/1991
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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