SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311

Saline, Vascular Access Flush

EXCELSIOR MEDICAL CORP.

The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Swabflsuh (3ml, 5ml, 10ml) Model 10331, 10351, 10311.

Pre-market Notification Details

Device IDK101270
510k NumberK101270
Device Name:SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
ClassificationSaline, Vascular Access Flush
Applicant EXCELSIOR MEDICAL CORP. 4 INNOVATION DRIVE Dundas, On,  CA L2h 7p3
ContactNancy Ruth
CorrespondentNancy Ruth
EXCELSIOR MEDICAL CORP. 4 INNOVATION DRIVE Dundas, On,  CA L2h 7p3
Product CodeNGT  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-06
Decision Date2011-02-10
Summary:summary

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