MANAN BILIARY DRAINAGE CATHETER

Stents, Drains And Dilators For The Biliary Ducts

MEDICAL DEVICE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Manan Biliary Drainage Catheter.

Pre-market Notification Details

Device IDK980191
510k NumberK980191
Device Name:MANAN BILIARY DRAINAGE CATHETER
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville,  FL  32608
ContactKarl Swartz
CorrespondentKarl Swartz
MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville,  FL  32608
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-20
Decision Date1998-02-09
Summary:summary

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