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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K010209
Device Name ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
Applicant
BIOMEDICAL LIFE SYSTEMS, INC.
P.O. BOX 1360
VISTA,  CA  92085 -1360
Applicant Contact RICHARD SAXON
Correspondent
BIOMEDICAL LIFE SYSTEMS, INC.
P.O. BOX 1360
VISTA,  CA  92085 -1360
Correspondent Contact RICHARD SAXON
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/23/2001
Decision Date 06/12/2001
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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