FDA 510(k) Application Details - K992194

Device Classification Name Electrode, Cortical

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510(K) Number K992194
Device Name Electrode, Cortical
Applicant AD-TECH MEDICAL INSTRUMENT CORP.
1901 WILLIAM ST.
RACINE, WI 53404-1876 US
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Contact JOHN F ZIOBRO
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Regulation Number 882.1310

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Classification Product Code GYC
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Date Received 06/29/1999
Decision Date 09/13/1999
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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