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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K870113
Device Name THERMAL JACKET FOR I.V. FLUID BAGS
Applicant
Thermal Medical Systems, Inc.
Rt. 2 Box 147
Astoria,  OR  97103
Applicant Contact ROBERT K SMITH
Correspondent
Thermal Medical Systems, Inc.
Rt. 2 Box 147
Astoria,  OR  97103
Correspondent Contact ROBERT K SMITH
Regulation Number880.5025
Classification Product Code
KPE  
Date Received01/12/1987
Decision Date 02/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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