EPISTAXIS BALLOON CATHETER WITH 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 Epistaxis Balloon Catheter With Packing.

Pre-market Notification Details

Device IDK945554
510k NumberK945554
Device Name:EPISTAXIS BALLOON CATHETER WITH PACKING
ClassificationBalloon, Epistaxis
Applicant ULTRACELL MEDICAL TECHNOLOGIES, INC. POST OFFICE BOX 609 Old Mystic,  CT  06372
ContactGeorge P Korteweg
CorrespondentGeorge P Korteweg
ULTRACELL MEDICAL TECHNOLOGIES, INC. POST OFFICE BOX 609 Old Mystic,  CT  06372
Product CodeEMX  
CFR Regulation Number874.4100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-14
Decision Date1995-02-17

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