ULTRACELL NASAL PACKING

Balloon, Epistaxis

ULTRACELL MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Ultracell Nasal Packing.

Pre-market Notification Details

Device IDK920358
510k NumberK920358
Device Name:ULTRACELL NASAL PACKING
ClassificationBalloon, Epistaxis
Applicant ULTRACELL MEDICAL TECHNOLOGIES, INC. P.O. BOX 326 North Stonington,  CT  06359
ContactGeorge P Korteweg
CorrespondentGeorge P Korteweg
ULTRACELL MEDICAL TECHNOLOGIES, INC. P.O. BOX 326 North Stonington,  CT  06359
Product CodeEMX  
CFR Regulation Number874.4100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-27
Decision Date1992-11-30

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