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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 K152364
Device Name uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
Applicant
Pc Marketing, Inc.
1040 Wilt Ave.
Ridgefield,  NJ  07657
Applicant Contact Michael Rolls
Correspondent
Bentley Biomedical Consulting, LLC
28241 Crown Valley Pkwy.
Laguna Niguel,  CA  92677
Correspondent Contact Shepard G. Bentley
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received08/21/2015
Decision Date 04/14/2016
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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