MANAN INTRODUCER SHEALTH/NEEDLE

Stents, Drains And Dilators For The Biliary Ducts

MANAN MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Introducer Shealth/needle.

Pre-market Notification Details

Device IDK961216
510k NumberK961216
Device Name:MANAN INTRODUCER SHEALTH/NEEDLE
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook,  IL  60062
ContactMichael Plishka
CorrespondentMichael Plishka
MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook,  IL  60062
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-28
Decision Date1996-05-23

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