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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 K952086
Device Name TROPICAIR CONVECTIVE WARMING BLANKETS
Applicant
Seabrook Medical Systems, Inc.
4043 Mcmann Rd.
Cincinnati,  OH  45245
Applicant Contact LAURA M CANNON
Correspondent
Seabrook Medical Systems, Inc.
4043 Mcmann Rd.
Cincinnati,  OH  45245
Correspondent Contact LAURA M CANNON
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received05/03/1995
Decision Date 09/06/1995
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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