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FDA 510(k) Application Details - K113724
Device Classification Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
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510(K) Number
K113724
Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant
PAIN RELIEF TECHNOLOGIES
15048 SW CAPSTONE CT.
BEAVERTON, OR 97007 US
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Contact
KENDALL GORHAM
Other 510(k) Applications for this Contact
Regulation Number
882.5890
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Classification Product Code
NFO
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More FDA Info for this Product Code
Date Received
12/19/2011
Decision Date
02/15/2012
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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