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FDA 510(k) Application Details - K161849
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
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510(K) Number
K161849
Device Name
Light Based Over The Counter Wrinkle Reduction
Applicant
Tanda Beauty Canada Inc.
11-380 Jamieson Parkway
Cambridge CA
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Contact
Bobae Kim
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
OHS
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More FDA Info for this Product Code
Date Received
07/05/2016
Decision Date
07/29/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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