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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Paraffin
510(k) Number K093100
Device Name REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)
Applicant
Shenzhen Comfort Technology Co., Ltd.
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Applicant Contact JEAN ASQUITH
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL LEHTONEN
Regulation Number890.5110
Classification Product Code
IMC  
Date Received10/01/2009
Decision Date 11/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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