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FDA 510(k) Application Details - K120511
Device Classification Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
More FDA Info for this Device
510(K) Number
K120511
Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant
LETO ENTERPRISE LTD.
308 HENNESSY RD
WANCHAI HONGKONG HK
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Contact
SABRINA WEI
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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
02/21/2012
Decision Date
07/30/2012
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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