ALBUMIN INTRAVENOUS ADMINISTRATION SET

Set, Administration, Intravascular

DELMED, INC.

The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Albumin Intravenous Administration Set.

Pre-market Notification Details

Device IDK791672
510k NumberK791672
Device Name:ALBUMIN INTRAVENOUS ADMINISTRATION SET
ClassificationSet, Administration, Intravascular
Applicant DELMED, INC. (SENT TO BUREAU OF DRUGS)
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-28
Decision Date1979-10-26

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