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FDA 510(k) Application Details - K964644
Device Classification Name
Electrode, Depth
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
882.1330
More FDA Info for this Regulation Number
Classification Product Code
GZL
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More FDA Info for this Product Code
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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