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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 K022626
Device Name MOISTURESTAY (REVLON)
Applicant
Raymond Industrial, Ltd.
972 Weedon Dr. NE
Saint Petersburg,  FL  33702
Applicant Contact ROBERT T WAGNER
Correspondent
Raymond Industrial, Ltd.
972 Weedon Dr. NE
Saint Petersburg,  FL  33702
Correspondent Contact ROBERT T WAGNER
Regulation Number890.5110
Classification Product Code
IMC  
Date Received08/07/2002
Decision Date 10/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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