CONTRAST MEDIA TRANSFER SETS

Set, Administration, Intravascular

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Contrast Media Transfer Sets.

Pre-market Notification Details

Device IDK052252
510k NumberK052252
Device Name:CONTRAST MEDIA TRANSFER SETS
ClassificationSet, Administration, Intravascular
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactChristine Ford
CorrespondentChristine Ford
B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-18
Decision Date2005-11-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.