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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 K931203
Device Name COOL-AID
Applicant
Seabrook Medical Systems, Inc.
673 Wilmer Ave.
Cincinnati,  OH  45226
Applicant Contact LAURA M CANNON
Correspondent
Seabrook Medical Systems, Inc.
673 Wilmer Ave.
Cincinnati,  OH  45226
Correspondent Contact LAURA M CANNON
Regulation Number890.5720
Classification Product Code
ILO  
Date Received03/09/1993
Decision Date 02/22/1994
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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