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FDA 510(k) Application Details - K152336
Device Classification Name
Booth, Sun Tan
More FDA Info for this Device
510(K) Number
K152336
Device Name
Booth, Sun Tan
Applicant
J & B PRODUCTS LTD DBA HEX TANNING
2201 S MICHIGAN AVENUE
SAGINAW, MI 48602 US
Other 510(k) Applications for this Company
Contact
LINDA BOMMARITO
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
08/19/2015
Decision Date
05/02/2016
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
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