LORENZ STENT

Prosthesis, Larynx (stents And Keels)

WALTER LORENZ SURGICAL, INC.

The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Stent.

Pre-market Notification Details

Device IDK896667
510k NumberK896667
Device Name:LORENZ STENT
ClassificationProsthesis, Larynx (stents And Keels)
Applicant WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville,  FL  32218
ContactDebra A Powers
CorrespondentDebra A Powers
WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville,  FL  32218
Product CodeFWN  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-27
Decision Date1990-02-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00841036025922 K896667 000

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