SWABBABLE CAP, MODEL 60205

Administration Set Docking Station

BAXA CORP.

The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Swabbable Cap, Model 60205.

Pre-market Notification Details

Device IDK070163
510k NumberK070163
Device Name:SWABBABLE CAP, MODEL 60205
ClassificationAdministration Set Docking Station
Applicant BAXA CORP. 14445 GRASSLANDS DR. Englewood,  CO  80112 -7062
ContactKimberly Zizik
CorrespondentKimberly Zizik
BAXA CORP. 14445 GRASSLANDS DR. Englewood,  CO  80112 -7062
Product CodeODI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-17
Decision Date2007-08-03
Summary:summary

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