510(k) K152336

HEX tanning booth by J & B Products Ltd Dba Hex Tanning — Product Code LEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2016
Date Received
August 19, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Booth, Sun Tan
Device Class
Class II
Regulation Number
878.4635
Review Panel
SU
Submission Type