TRANSDUCER PROTECTOR

Filter, Blood, Dialysis

TERUMO AMERICA, INC.

The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Transducer Protector.

Pre-market Notification Details

Device IDK772040
510k NumberK772040
Device Name:TRANSDUCER PROTECTOR
ClassificationFilter, Blood, Dialysis
Applicant TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFKJ  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-10-28
Decision Date1977-11-28

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