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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 K013707
Device Name SOFTIQUE, MODEL GI 11001
Applicant
Global TV Concepts, Ltd.
676 S. Military Trl.
Deerfield Beach,  FL  33442
Applicant Contact LAURIE BRADEN
Correspondent
Global TV Concepts, Ltd.
676 S. Military Trl.
Deerfield Beach,  FL  33442
Correspondent Contact LAURIE BRADEN
Regulation Number890.5110
Classification Product Code
IMC  
Date Received11/08/2001
Decision Date 02/01/2002
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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