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FDA 510(k) Application Details - K020400
Device Classification Name
Stimulator, Electrical, Evoked Response
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510(K) Number
K020400
Device Name
Stimulator, Electrical, Evoked Response
Applicant
MEPS, LLC.
ONE EAST BROWARD BLVD #700
FORT LAUDERDALE, FL 33301 US
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Contact
HARRY BENEDICT
Other 510(k) Applications for this Contact
Regulation Number
882.1870
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Classification Product Code
GWF
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More FDA Info for this Product Code
Date Received
02/06/2002
Decision Date
08/23/2002
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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