MENTOR CONTOUR PROFILE TISSUE EXPANDER

Expander, Skin, Inflatable

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Contour Profile Tissue Expander.

Pre-market Notification Details

Device IDK011500
510k NumberK011500
Device Name:MENTOR CONTOUR PROFILE TISSUE EXPANDER
ClassificationExpander, Skin, Inflatable
Applicant MENTOR CORP. 201 MENTOR DR. Santa Barbara,  CA  93111
ContactDonna Crawford
CorrespondentDonna Crawford
MENTOR CORP. 201 MENTOR DR. Santa Barbara,  CA  93111
Product CodeLCJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-16
Decision Date2001-12-03

NIH GUDID Devices

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