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FDA 510(k) Application Details - K162630
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
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510(K) Number
K162630
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
Mid-America Medical Innovations LLC
2704 Industrial Drive
Jefferson City, MO 65109 US
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Contact
Norm Schroeder
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
NUH
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More FDA Info for this Product Code
Date Received
09/21/2016
Decision Date
12/20/2016
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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