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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Blood, Non-Electromagnetic Radiation
510(k) Number K112639
Device Name THE BELMONT BUDDY LITE FLUID WARMER
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 Number864.9205
Classification Product Code
BSB  
Date Received09/12/2011
Decision Date 11/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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