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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Vocal Cord Medialization
510(k) Number K011554
Device Name LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
Applicant
BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number874.3620
Classification Product Code
MIX  
Date Received05/18/2001
Decision Date 06/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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