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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 K022925
Device Name ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
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 Received09/04/2002
Decision Date 11/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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