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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filter, blood, dialysis
510(k) Number K772040
Device Name TRANSDUCER PROTECTOR
Applicant
TERUMO AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TERUMO AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5820
Classification Product Code
FKJ  
Date Received10/28/1977
Decision Date 11/28/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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