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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 K884255
Device Name CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
Applicant
Concept, Inc.
11311 Concept Blvd.
Largo,  FL  34643
Applicant Contact MARTHA C MILLER
Correspondent
Concept, Inc.
11311 Concept Blvd.
Largo,  FL  34643
Correspondent Contact MARTHA C MILLER
Regulation Number890.5720
Classification Product Code
ILO  
Date Received10/11/1988
Decision Date 11/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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