FDA 510(k) Application Details - K041409

Device Classification Name Electrode, Depth

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510(K) Number K041409
Device Name Electrode, Depth
Applicant INOMED GMBH
KUNGSTENSGATAN 18, PO BX 7593
SE-103 93 STOCKHOLM SE
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Contact ANDERS SKOGLUND
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Regulation Number 882.1330

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Classification Product Code GZL
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Date Received 05/27/2004
Decision Date 08/20/2004
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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