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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, larynx (stents and keels)
510(k) Number K896667
Device Name LORENZ STENT
Applicant
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Applicant Contact DEBRA A POWERS
Correspondent
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Correspondent Contact DEBRA A POWERS
Regulation Number874.3620
Classification Product Code
FWN  
Date Received11/27/1989
Decision Date 02/22/1990
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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