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FDA 510(k) Application Details - K150826
Device Classification Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
More FDA Info for this Device
510(K) Number
K150826
Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant
NUTRA LUXE MD, LLC
6835 INTERNATIONAL CENTER BLVD UNIT 4-5
FORT MYERS, FL 33912 US
Other 510(k) Applications for this Company
Contact
PETER VON BERG
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
NFO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/30/2015
Decision Date
02/10/2016
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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