FDA 510(k) Application Details - K061224

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K061224
Device Name Neurological Stereotaxic Instrument
Applicant ROBODENT GMBH
KURFURSTENDAMM 213
BERLIN 10719 DE
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Contact JUERGEN BIER
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 05/01/2006
Decision Date 09/05/2006
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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