MENTOR TISSUE EXPANDERS W/TDMAC COATING

Expander, Skin, Inflatable

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Tissue Expanders W/tdmac Coating.

Pre-market Notification Details

Device IDK894475
510k NumberK894475
Device Name:MENTOR TISSUE EXPANDERS W/TDMAC COATING
ClassificationExpander, Skin, Inflatable
Applicant MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
ContactTerry A Thompson
CorrespondentTerry A Thompson
MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
Product CodeLCJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-18
Decision Date1990-11-26

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