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FDA 510(k) Application Details - K173565
Device Classification Name
Booth, Sun Tan
More FDA Info for this Device
510(K) Number
K173565
Device Name
Booth, Sun Tan
Applicant
JK-Holding GmbH
Koehlershohner Strasse 60
Windhagen 53578 DE
Other 510(k) Applications for this Company
Contact
Juergen Gerstenmeier
Other 510(k) Applications for this Contact
Regulation Number
878.4635
More FDA Info for this Regulation Number
Classification Product Code
LEJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/17/2017
Decision Date
02/14/2018
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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