FDA 510(k) Application Details - K010782

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

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510(K) Number K010782
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant TRANSAMERICA MEDICAL SYSTEMS
350 RACE ST.
HOLYOKE, MA 01040 US
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Contact JOHN F DUNN
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 03/15/2001
Decision Date 04/27/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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