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FDA 510(k) Application Details - K992596
Device Classification Name
Stimulator, Nerve, Peripheral, Electric
More FDA Info for this Device
510(K) Number
K992596
Device Name
Stimulator, Nerve, Peripheral, Electric
Applicant
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM, NC 27712 US
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Contact
REBECCA A RIVAS
Other 510(k) Applications for this Contact
Regulation Number
868.2775
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Classification Product Code
KOI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/1999
Decision Date
08/30/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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