COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT

Prosthesis, Esophageal

COOK, INC.

The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Coverd Gianturco-rosch Esophageal Z-stent.

Pre-market Notification Details

Device IDK945201
510k NumberK945201
Device Name:COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
ClassificationProsthesis, Esophageal
Applicant COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington,  IN  47402
ContactApril Lavender
CorrespondentApril Lavender
COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington,  IN  47402
Product CodeESW  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-25
Decision Date1995-01-04

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