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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 K021270
Device Name ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2
Applicant
BIOMEDICAL LIFE SYSTEMS
P.O. BOX 1360
VISTA,  CA  92085
Applicant Contact HANS REISS
Correspondent
BIOMEDICAL LIFE SYSTEMS
P.O. BOX 1360
VISTA,  CA  92085
Correspondent Contact HANS REISS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/22/2002
Decision Date 02/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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