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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ear, Nose And Throat, Synthetic, Absorbable
510(k) Number K012409
Device Name LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
Applicant
Walter Lorenz Surgical, Inc.
1520 Tradeport Dr.
Jacksonville,  FL  32218
Applicant Contact SHERYL MALMBERG
Correspondent
Walter Lorenz Surgical, Inc.
1520 Tradeport Dr.
Jacksonville,  FL  32218
Correspondent Contact SHERYL MALMBERG
Regulation Number874.3620
Classification Product Code
NHB  
Date Received07/30/2001
Decision Date 10/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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