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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 K013328
Device Name REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
Applicant
Remington Products Company, LLC
1400 Sixteenth St., NW
Suite 400
Washington,  DC  20036
Applicant Contact PAMELA J FURMAN
Correspondent
Remington Products Company, LLC
1400 Sixteenth St., NW
Suite 400
Washington,  DC  20036
Correspondent Contact PAMELA J FURMAN
Regulation Number890.5110
Classification Product Code
IMC  
Date Received10/05/2001
Decision Date 12/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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