FDA 510(k) Application Details - K052745

Device Classification Name Endoscope, Neurological

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510(K) Number K052745
Device Name Endoscope, Neurological
Applicant GEOMED MEDIZIN-TECHNIK GMBH & CO.
AMSTEL 320-I
AMSTERDAM 1017AP NL
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Contact ANGELIKA SCHERP
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Regulation Number 882.1480

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Classification Product Code GWG
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Date Received 09/30/2005
Decision Date 11/23/2005
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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