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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Booth, Sun Tan
510(k) Number K090831
Device Name TANTHERA-T35
Applicant
Tanthera, Inc.
3000 K St. NW
Suite 500
Washington,  DC  20007
Applicant Contact NATHAN A BEAVER, ESQ
Correspondent
Tanthera, Inc.
3000 K St. NW
Suite 500
Washington,  DC  20007
Correspondent Contact NATHAN A BEAVER, ESQ
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received03/26/2009
Decision Date 05/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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