Lockbox For Perfusor Space PCA Infusion Pump

Accessories, 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 Lockbox For Perfusor Space Pca Infusion Pump.

Pre-market Notification Details

Device IDK173531
510k NumberK173531
Device Name:Lockbox For Perfusor Space PCA Infusion Pump
ClassificationAccessories, Pump, Infusion
Applicant B. Braun Medical Inc. 901 Marcon Blvd Allentown,  PA  18109
ContactTracy Maddock
CorrespondentTracy Maddock
B. Braun Medical Inc. 901 Marcon Blvd Allentown,  PA  18109
Product CodeMRZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-15
Decision Date2018-08-02

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