FDA 510(k) Application Details - K090831

Device Classification Name Booth, Sun Tan

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510(K) Number K090831
Device Name Booth, Sun Tan
Applicant TANTHERA, INC.
3000 K STREET NW
SUITE 500
WASHINGTON, DC 20007 US
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Contact NATHAN A BEAVER, ESQ
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 03/26/2009
Decision Date 05/29/2009
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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