FDA 510(k) Application Details - K964644

Device Classification Name Electrode, Depth

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510(K) Number K964644
Device Name Electrode, Depth
Applicant AD-TECH MEDICAL INSTRUMENT CORP.
1901 WILLIAM ST.
RACINE, WI 53404-1876 US
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Contact DAVID A PUTZ
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Regulation Number 882.1330

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Classification Product Code GZL
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Date Received 10/31/1996
Decision Date 05/09/1997
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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