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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 K902268
Device Name PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.
Applicant
Seabrook Medical Systems, Inc.
673 Wilmer Ave.
Cincinnati,  OH  45226
Applicant Contact MARK J BUCH
Correspondent
Seabrook Medical Systems, Inc.
673 Wilmer Ave.
Cincinnati,  OH  45226
Correspondent Contact MARK J BUCH
Regulation Number890.5720
Classification Product Code
ILO  
Date Received05/21/1990
Decision Date 06/21/1990
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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