INFUSOMAT P

Pump, Infusion

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Infusomat P.

Pre-market Notification Details

Device IDK003029
510k NumberK003029
Device Name:INFUSOMAT P
ClassificationPump, Infusion
Applicant B. BRAUN MEDICAL, INC. 1601 WALLACE DR., SUITE 150 Carrollton,  TX  75006
ContactGary A Gultas
CorrespondentGary A Gultas
B. BRAUN MEDICAL, INC. 1601 WALLACE DR., SUITE 150 Carrollton,  TX  75006
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-28
Decision Date2000-12-04

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