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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 K760012
Device Name BLOOD WARMER (CODE 4R4305)
Applicant
TRAVENOL LABORATORIES, S.A.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TRAVENOL LABORATORIES, S.A.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.9205
Classification Product Code
BSB  
Date Received06/10/1976
Decision Date 07/16/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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