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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 K031478
Device Name MICROHEATER
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  
Subsequent Product Code
LGZ  
Date Received05/12/2003
Decision Date 07/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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