LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT

System, Vocal Cord Medialization

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lorenz Lactosorb Vocal Medialization Implant.

Pre-market Notification Details

Device IDK011554
510k NumberK011554
Device Name:LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
ClassificationSystem, Vocal Cord Medialization
Applicant BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
Product CodeMIX  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-18
Decision Date2001-06-26

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