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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 K902269
Device Name ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
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 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
Recalls CDRH Recalls
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