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FDA 510(k) Application Details - K113321
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
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510(K) Number
K113321
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
SAVIA LIMITED
11820 RED HIBISCUS
BONITA SPRINGS, FL 34135 US
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Contact
GUENTER GINSBERG
Other 510(k) Applications for this Contact
Regulation Number
882.5890
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Classification Product Code
NUH
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More FDA Info for this Product Code
Date Received
11/10/2011
Decision Date
09/04/2012
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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