FDA 510(k) Application Details - K964646

Device Classification Name Nystagmograph

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510(K) Number K964646
Device Name Nystagmograph
Applicant MICROMEDICAL TECHNOLOGIES, INC.
110 WEST WALNUT
CHATHAM, IL 62629 US
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Contact MANISH SUMANT
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Regulation Number 882.1460

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Classification Product Code GWN
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Date Received 11/20/1996
Decision Date 07/15/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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