EXPANDACEL NASAL TAMPONS

Balloon, Epistaxis

SURGITREND, LTD.

The following data is part of a premarket notification filed by Surgitrend, Ltd. with the FDA for Expandacel Nasal Tampons.

Pre-market Notification Details

Device IDK900171
510k NumberK900171
Device Name:EXPANDACEL NASAL TAMPONS
ClassificationBalloon, Epistaxis
Applicant SURGITREND, LTD. 6099 SOUTH QUEBEC ST. #200 Englewood,  CO  80111
ContactShippert, Md
CorrespondentShippert, Md
SURGITREND, LTD. 6099 SOUTH QUEBEC ST. #200 Englewood,  CO  80111
Product CodeEMX  
CFR Regulation Number874.4100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-12
Decision Date1990-06-14

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