MEDRON Vessel Dilator - 6F X 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator

Dilator, Vessel, For Percutaneous Catheterization

Medron, LLC

The following data is part of a premarket notification filed by Medron, Llc with the FDA for Medron Vessel Dilator - 6f X 22cm Hdpe Dilator, Medron Vessel Dilator - 15.5f - 17.5f Hdpe Dilator.

Pre-market Notification Details

Device IDK192283
510k NumberK192283
Device Name:MEDRON Vessel Dilator - 6F X 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant Medron, LLC 1518 S Gladiola Street Salt Lake City,  UT  84104
ContactDavid Kujawa
CorrespondentDavid Kujawa
Medron, LLC 1518 S Gladiola Street Salt Lake City,  UT  84104
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2020-05-06

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