ESOPHAGEAL Z-STENT

Prosthesis, Esophageal

WILSON-COOK MEDICAL, INC.

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

Pre-market Notification Details

Device IDK920218
510k NumberK920218
Device Name:ESOPHAGEAL Z-STENT
ClassificationProsthesis, Esophageal
Applicant WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
ContactRichard Marshall
CorrespondentRichard Marshall
WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
Product CodeESW  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-16
Decision Date1994-02-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.