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FDA 510(k) Application Details - K152412
Device Classification Name
Booth, Sun Tan
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510(K) Number
K152412
Device Name
Booth, Sun Tan
Applicant
Tanses Technologies inc.
4450 Highway 13
Fabreville H7R 6E9 CA
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Contact
Kirk Kiremitci
Other 510(k) Applications for this Contact
Regulation Number
878.4635
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Classification Product Code
LEJ
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More FDA Info for this Product Code
Date Received
08/26/2015
Decision Date
04/29/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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