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FDA 510(k) Application Details - K151905
Device Classification Name
Booth, Sun Tan
More FDA Info for this Device
510(K) Number
K151905
Device Name
Booth, Sun Tan
Applicant
HEARTLAND TANNING, INC.
4251 NE Port Dr.
Lees Summit, MO 64064 US
Other 510(k) Applications for this Company
Contact
Jon Marcum
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
07/13/2015
Decision Date
03/01/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K151905
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