HAEMOTROL MODEL #HT-SB/6 BURETTE SET

Set, Administration, Intravascular

HAEMOTRONIC, INC.

The following data is part of a premarket notification filed by Haemotronic, Inc. with the FDA for Haemotrol Model #ht-sb/6 Burette Set.

Pre-market Notification Details

Device IDK921594
510k NumberK921594
Device Name:HAEMOTROL MODEL #HT-SB/6 BURETTE SET
ClassificationSet, Administration, Intravascular
Applicant HAEMOTRONIC, INC. 45 KULICK RD. Fairfield,  NJ  07004
ContactWiller Ghelfi
CorrespondentWiller Ghelfi
HAEMOTRONIC, INC. 45 KULICK RD. Fairfield,  NJ  07004
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-03
Decision Date1992-12-24

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