EPI-STOP EPISTAXIS CATHETER

Balloon, Epistaxis

BOSTON MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Epi-stop Epistaxis Catheter.

Pre-market Notification Details

Device IDK972077
510k NumberK972077
Device Name:EPI-STOP EPISTAXIS CATHETER
ClassificationBalloon, Epistaxis
Applicant BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough,  MA  01581
ContactStuart K Montgomery
CorrespondentStuart K Montgomery
BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough,  MA  01581
Product CodeEMX  
CFR Regulation Number874.4100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-03
Decision Date1997-06-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EBES60401P0 K972077 000
EBES604010 K972077 000

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