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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 K033455
Device Name ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
Applicant
Biomedical Life Systems, Inc.
P.O. Box 1360
Vista,  CA  92085
Applicant Contact DONNA HERATY
Correspondent
Biomedical Life Systems, Inc.
P.O. Box 1360
Vista,  CA  92085
Correspondent Contact DONNA HERATY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/30/2003
Decision Date 01/15/2004
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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