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FDA 510(k) Application Details - K993130
Device Classification Name
Electrode, Cutaneous
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510(K) Number
K993130
Device Name
Electrode, Cutaneous
Applicant
NEWWAVE MEDICAL LLC.
1538 HAVEN PLACE
ALLEN, TX 75002 US
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Contact
ROBERT ARMSTRONG
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Regulation Number
882.1320
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Classification Product Code
GXY
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More FDA Info for this Product Code
Date Received
09/20/1999
Decision Date
12/17/1999
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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