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FDA 510(k) Application Details - K180581
Device Classification Name
Booth, Sun Tan
More FDA Info for this Device
510(K) Number
K180581
Device Name
Booth, Sun Tan
Applicant
Feilo Sylvania Germany GmbH
Graf-Zepplin-Str.9
Erlangen DE
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Contact
Achim Tonat
Other 510(k) Applications for this Contact
Regulation Number
878.4635
More FDA Info for this Regulation Number
Classification Product Code
LEJ
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More FDA Info for this Product Code
Date Received
03/01/2018
Decision Date
06/22/2018
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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