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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K902756
Device Name TROPI-COOL
Applicant
Seabrook Medical Systems, Inc.
673 Wilmer Ave.
Cincinnati,  OH  45226 -1859
Applicant Contact MARK J BUCH
Correspondent
Seabrook Medical Systems, Inc.
673 Wilmer Ave.
Cincinnati,  OH  45226 -1859
Correspondent Contact MARK J BUCH
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/22/1990
Decision Date 10/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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