BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR

Prosthesis, Esophageal

ENDOCHOICE, INC.

The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Bonastent Esophageal, Models Be And Ber, Bonastent Esophageal U.e.s. Flange And Flare, Models Befg And Befr.

Pre-market Notification Details

Device IDK092144
510k NumberK092144
Device Name:BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
ClassificationProsthesis, Esophageal
Applicant ENDOCHOICE, INC. 1914 J.N. PEASE PLACE Charlotte,  NC  28262
ContactShoshana Friedman
CorrespondentShoshana Friedman
ENDOCHOICE, INC. 1914 J.N. PEASE PLACE Charlotte,  NC  28262
Product CodeESW  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-15
Decision Date2010-02-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806369459105 K092144 000
08806369458528 K092144 000
08806369458542 K092144 000
08806369458566 K092144 000
08806369458580 K092144 000
08806369458603 K092144 000
08806369459006 K092144 000
08806369459020 K092144 000
08806369459044 K092144 000
08806369459068 K092144 000
08806369459082 K092144 000
08806369458504 K092144 000

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