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FDA 510(k) Application Details - K190269
Device Classification Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
More FDA Info for this Device
510(K) Number
K190269
Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant
Xtreem Pulse, LLC
353 W. 29 St., Suite 3
New York, NY 10001 US
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Contact
Andrew Berile
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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
02/08/2019
Decision Date
08/28/2019
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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