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FDA 510(k) Application Details - K133502
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
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510(K) Number
K133502
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
PRIZM MEDICAL, INC.
2888 FOREST RIDGE
CHASKA, MN 55318 US
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Contact
CARL BEAURLINE
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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
11/14/2013
Decision Date
12/03/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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