510(k) K152412
K152412 is an FDA 510(k) premarket notification submitted by Tanses Technologies, Inc. for the device "T-32;T-40;T-44;T-52;T-72;TT-50". The FDA issued a decision of Substantially Equivalent on April 29, 2016. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635. Tanses Technologies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2016
- Date Received
- August 26, 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