RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM

Prosthesis, Esophageal

RUSCH INTL.

The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Polyflex Stent For The Esophagus With Introducer System.

Pre-market Notification Details

Device IDK010068
510k NumberK010068
Device Name:RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
ClassificationProsthesis, Esophageal
Applicant RUSCH INTL. 50 PLANTATION DR. Jaffery,  NH  03452
ContactKarenann J Brozowski
CorrespondentKarenann J Brozowski
RUSCH INTL. 50 PLANTATION DR. Jaffery,  NH  03452
Product CodeESW  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-01-08
Decision Date2001-02-08

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