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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Water Circulating
510(k) Number K961621
Device Name THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM
Applicant
THERAPY CONCEPTS, INC.
15 FOXHUNT DR.
CHESTERFIELD,  MO  63017
Applicant Contact JAMES TAYLOR
Correspondent
THERAPY CONCEPTS, INC.
15 FOXHUNT DR.
CHESTERFIELD,  MO  63017
Correspondent Contact JAMES TAYLOR
Regulation Number890.5720
Classification Product Code
ILO  
Date Received04/26/1996
Decision Date 10/31/1996
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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