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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K060851
Device Name SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER
Applicant
The Smithworks Company
2615 102nd Ave. NE
Bellevue,  WA  98004
Applicant Contact PATRICIA A MILBANK
Correspondent
The Smithworks Company
2615 102nd Ave. NE
Bellevue,  WA  98004
Correspondent Contact PATRICIA A MILBANK
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received03/28/2006
Decision Date 12/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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