MENTOR PATHWAY INTRODUCER/DILATOR

System, Suction, Lipoplasty

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Pathway Introducer/dilator.

Pre-market Notification Details

Device IDK981527
510k NumberK981527
Device Name:MENTOR PATHWAY INTRODUCER/DILATOR
ClassificationSystem, Suction, Lipoplasty
Applicant MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara,  CA  93111
ContactDonna A Crawford
CorrespondentDonna A Crawford
MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara,  CA  93111
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-28
Decision Date1998-07-09
Summary:summary

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