FDA 510(k) Application Details - K092117

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

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510(K) Number K092117
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant RITM OKB ZAO
99, PETROVSKAYA
TAGANROG 347900 RU
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Contact LARISA SHPUNGINA
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 07/14/2009
Decision Date 05/28/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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