WILSON-COOK COLONIC Z-STENT

Stent, Colonic, Metallic, Expandable

MED INSTITUTE, INC.

The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Wilson-cook Colonic Z-stent.

Pre-market Notification Details

Device IDK990034
510k NumberK990034
Device Name:WILSON-COOK COLONIC Z-STENT
ClassificationStent, Colonic, Metallic, Expandable
Applicant MED INSTITUTE, INC. 1400 CUMBERLAND AVE. P.O. BOX 2402 West Lafayette,  IN  47906
ContactNeal E Fearnot
CorrespondentNeal E Fearnot
MED INSTITUTE, INC. 1400 CUMBERLAND AVE. P.O. BOX 2402 West Lafayette,  IN  47906
Product CodeMQR  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-06
Decision Date2000-04-17
Summary:summary

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