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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 K032778
Device Name LARGE VOLUME FLUID RESERVOIR
Applicant
Belmont Instrument Corp.
780 Boston Rd.
Billerica,  MA  01821
Applicant Contact URAIWAN P LABADINI
Correspondent
Belmont Instrument Corp.
780 Boston Rd.
Billerica,  MA  01821
Correspondent Contact URAIWAN P LABADINI
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received09/08/2003
Decision Date 09/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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