FDA 510(k) Application Details - K021270

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K021270
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant BIOMEDICAL LIFE SYSTEMS
P.O. BOX 1360
VISTA, CA 92085 US
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Contact HANS REISS
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 04/22/2002
Decision Date 02/06/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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